Tyber Medical A.L.P.S. mvX Plates Recalled for Screw Locking Failure

Agency Publication Date: February 21, 2025

Summary

Tyber Medical is recalling 4,149 units of A.L.P.S. mvX Medial Tibia and Anatomic Lateral Fibula plates because the locking screws can pass completely through the locking holes during surgery. This mechanical failure prevents the hardware from properly stabilizing bone fractures as intended. Several incidents of surgical delays have been reported because the defect was discovered while the patient was undergoing a procedure.

Risk

If the screw fails to lock into the plate during surgery, doctors may need to find alternative hardware or change surgical plans, which extends the time a patient spends under anesthesia. This defect could also result in improper bone fixation if not identified and corrected during the operation.

What You Should Do

This recall affects Tyber Medical A.L.P.S. mvX series hardware, including Anatomic Lateral Fibula Plates (4 to 12 holes) and Medial Tibia Plates (6 to 16 holes) in both left and right configurations. See the Affected Products section below for the full list of affected codes.
Stop using the recalled surgical plates immediately and quarantine any remaining inventory from surgical kits.
Contact Tyber Medical or your authorized medical distributor to arrange for the return, replacement, or correction of the affected devices.
If you have questions regarding this recall, contact Tyber Medical directly through your sales representative or authorized distributor.
Call the FDA at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov/medical-devices/medical-device-recalls for more information.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 4H LT (4-hole, Left)

Variants: 4-hole, Left

Model / REF:

770708041

Lot Numbers:

24043BU03

267844

24043BU02

261286

UDI:

00196449015528

Recall #: Z-1209-2025; Quantity: 412 units

Product: A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 4H RT (4-hole, Right)

Variants: 4-hole, Right

Model / REF:

770708042

Lot Numbers:

267845

261287

265780

24033BU01

UDI:

00196449015535

Recall #: Z-1210-2025; Quantity: 397 units

Product: A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 6H LT (6-hole, Left)

Variants: 6-hole, Left

Model / REF:

770708061

Lot Numbers:

267846

265782

24043BU04

261288

UDI:

00196449015542

Recall #: Z-1211-2025; Quantity: 418 units

Product: A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 6H RT (6-hole, Right)

Variants: 6-hole, Right

Model / REF:

770708062

Lot Numbers:

265783

267847

24036BU02

261289

UDI:

00196449015559

Recall #: Z-1212-2025; Quantity: 408 units

Product: A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 8H LT (8-hole, Left)

Variants: 8-hole, Left

Model / REF:

770708081

Lot Numbers:

265784

24043BU01

261290

UDI:

00196449015566

Recall #: Z-1213-2025; Quantity: 214 units

Product: A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 8H RT (8-hole, Right)

Variants: 8-hole, Right

Model / REF:

77070802

Lot Numbers:

265785

24036BU01

261291

UDI:

00196449015573

Recall #: Z-1214-2025; Quantity: 212 units

Product: A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 10H LT (10-hole, Left)

Variants: 10-hole, Left

Model / REF:

770708101

Lot Numbers:

269171

265809

262558

260891

UDI:

00196449015580

Recall #: Z-1215-2025; Quantity: 220 units

Product: A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 10H RT (10-hole, Right)

Variants: 10-hole, Right

Model / REF:

770708102

Lot Numbers:

265810

260892

262559

UDI:

00196449015597

Recall #: Z-1216-2025; Quantity: 219 units

Product: A.L.P.S. mvX-P: ANATOMIC LAT FIB PLATE 12H LT (12-hole, Left)

Variants: 12-hole, Left

Model / REF:

770708121

Lot Numbers:

262560

260893

UDI:

00196449015603

Recall #: Z-1217-2025; Quantity: 100 units

Product: A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 12H RT (12-hole, Right)

Variants: 12-hole, Right

Model / REF:

770708122

Lot Numbers:

262571

260894

UDI:

00196449015610

Recall #: Z-1218-2025; Quantity: 115 units

Product: A.L.P.S. mvX - MEDIAL TIBIA PLATE 6H LT (6-hole, Left)

Variants: 6-hole, Left

Model / REF:

770715061

Lot Numbers:

265790

263514

24055DF05

24056DF01

UDI:

00196449015979

Recall #: Z-1219-2025; Quantity: 197 units

Product: A.L.P.S. mvX - MEDIAL TIBIA PLATE 6H RT (6-hole, Right)

Variants: 6-hole, Right

Model / REF:

770715062

Lot Numbers:

265792

24053DF01

24065DF06

24052DF01

UDI:

00196449015986

Recall #: Z-1220-2025; Quantity: 210 units

Product: A.L.P.S. mvX - MEDIAL TIBIA PLATE 10H LT (10-hole, Left)

Variants: 10-hole, Left

Model / REF:

770715101

Lot Numbers:

265814

24060DF02

24065DF03

24060DF01

24065DF05

263512

UDI:

00196449015993

Recall #: Z-1221-2025; Quantity: 200 units

Product: A.L.P.S. mvX - MEDIAL TIBIA PLATE 10H RT (10-hole, Right)

Variants: 10-hole, Right

Model / REF:

770715102

Lot Numbers:

265815

24055DF03

24055DF04

UDI:

00196449016006

Recall #: Z-1222-2025; Quantity: 209 units

Product: A.L.P.S. mvX - MEDIAL TIBIA PLATE 12H LT (12-hole, Left)

Variants: 12-hole, Left

Model / REF:

770715121

Lot Numbers:

265816

24064DF01

263557

24065DF04

24059DF03

24059DF02

UDI:

00196449016013

Recall #: Z-1223-2025; Quantity: 201 units

Product: A.L.P.S. mvX - MEDIAL TIBIA PLATE 12H RT (12-hole, Right)

Variants: 12-hole, Right

Model / REF:

770715122

Lot Numbers:

265817

24060DF08

263511

24057DF02

24057DF04

UDI:

00196449016020

Recall #: Z-1224-2025; Quantity: 208 units

Product: A.L.P.S. mvX - MEDIAL TIBIA PLATE 16H LT (16-hole, Left)

Variants: 16-hole, Left

Model / REF:

770715161

Lot Numbers:

24061DF01

24065DF02

24070DF01

UDI:

00196449016037

Recall #: Z-1225-2025; Quantity: 100 units

Product: A.L.P.S. mvX - MEDIAL TIBIA PLATE 16H RT (16-hole, Right)

Variants: 16-hole, Right

Model / REF:

770715162

Lot Numbers:

24053DF02

24070DF02

24057DF01

UDI:

00196449016044

Recall #: Z-1226-2025; Quantity: 109 units

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96212

Status: Active

Manufacturer: Tyber Medical

Sold By: authorized medical distributors

Manufactured In: United States

Units Affected: 18 products (412 units; 397; 418 units; 408; 214 units; 212 units; 220 units; 219 units; 100 units; 115 units; 197 units; 210 units; 200 units; 209 units; 201 units; 208 units; 100 units; 109 units)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Tyber Medical A.L.P.S. mvX series hardware, including Anatomic Lateral Fibula Plates (4 to 12 holes) and Medial Tibia Plates (6 to 16 holes) in both left and right configurations. See the Affected Products section below for the full list of affected codes.

Stop using the recalled surgical plates immediately and quarantine any remaining inventory from surgical kits.

Contact Tyber Medical or your authorized medical distributor to arrange for the return, replacement, or correction of the affected devices.

If you have questions regarding this recall, contact Tyber Medical directly through your sales representative or authorized distributor.

Call the FDA at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov/medical-devices/medical-device-recalls for more information.

Affected Products

Product: A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 4H LT (4-hole, Left)

Variants: 4-hole, Left

Model / REF:

770708041

Lot Numbers:

24043BU03

267844

24043BU02

261286

UDI:

00196449015528

Recall #: Z-1209-2025; Quantity: 412 units

Product: A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 4H RT (4-hole, Right)

Variants: 4-hole, Right

Model / REF:

770708042

Lot Numbers:

267845

261287

265780

24033BU01

UDI:

00196449015535

Recall #: Z-1210-2025; Quantity: 397 units

Product: A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 6H LT (6-hole, Left)

Variants: 6-hole, Left

Model / REF:

770708061

Lot Numbers:

267846

265782

24043BU04

261288

UDI:

00196449015542

Recall #: Z-1211-2025; Quantity: 418 units

Product: A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 6H RT (6-hole, Right)

Variants: 6-hole, Right

Model / REF:

770708062

Lot Numbers:

265783

267847

24036BU02

261289

UDI:

00196449015559

Recall #: Z-1212-2025; Quantity: 408 units

Product: A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 8H LT (8-hole, Left)

Variants: 8-hole, Left

Model / REF:

770708081

Lot Numbers:

265784

24043BU01

261290

UDI:

00196449015566

Recall #: Z-1213-2025; Quantity: 214 units

Product: A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 8H RT (8-hole, Right)

Variants: 8-hole, Right

Model / REF:

77070802

Lot Numbers:

265785

24036BU01

261291

UDI:

00196449015573

Recall #: Z-1214-2025; Quantity: 212 units

Product: A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 10H LT (10-hole, Left)

Variants: 10-hole, Left

Model / REF:

770708101

Lot Numbers:

269171

265809

262558

260891

UDI:

00196449015580

Recall #: Z-1215-2025; Quantity: 220 units

Product: A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 10H RT (10-hole, Right)

Variants: 10-hole, Right

Model / REF:

770708102

Lot Numbers:

265810

260892

262559

UDI:

00196449015597

Recall #: Z-1216-2025; Quantity: 219 units

Product: A.L.P.S. mvX-P: ANATOMIC LAT FIB PLATE 12H LT (12-hole, Left)

Variants: 12-hole, Left

Model / REF:

770708121

Lot Numbers:

262560

260893

UDI:

00196449015603

Recall #: Z-1217-2025; Quantity: 100 units

Product: A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 12H RT (12-hole, Right)

Variants: 12-hole, Right

Model / REF:

770708122

Lot Numbers:

262571

260894

UDI:

00196449015610

Recall #: Z-1218-2025; Quantity: 115 units

Product: A.L.P.S. mvX - MEDIAL TIBIA PLATE 6H LT (6-hole, Left)

Variants: 6-hole, Left

Model / REF:

770715061

Lot Numbers:

265790

263514

24055DF05

24056DF01

UDI:

00196449015979

Recall #: Z-1219-2025; Quantity: 197 units

Product: A.L.P.S. mvX - MEDIAL TIBIA PLATE 6H RT (6-hole, Right)

Variants: 6-hole, Right

Model / REF:

770715062

Lot Numbers:

265792

24053DF01

24065DF06

24052DF01

UDI:

00196449015986

Recall #: Z-1220-2025; Quantity: 210 units

Product: A.L.P.S. mvX - MEDIAL TIBIA PLATE 10H LT (10-hole, Left)

Variants: 10-hole, Left

Model / REF:

770715101

Lot Numbers:

265814

24060DF02

24065DF03

24060DF01

24065DF05

263512

UDI:

00196449015993

Recall #: Z-1221-2025; Quantity: 200 units

Product: A.L.P.S. mvX - MEDIAL TIBIA PLATE 10H RT (10-hole, Right)

Variants: 10-hole, Right

Model / REF:

770715102

Lot Numbers:

265815

24055DF03

24055DF04

UDI:

00196449016006

Recall #: Z-1222-2025; Quantity: 209 units

Product: A.L.P.S. mvX - MEDIAL TIBIA PLATE 12H LT (12-hole, Left)

Variants: 12-hole, Left

Model / REF:

770715121

Lot Numbers:

265816

24064DF01

263557

24065DF04

24059DF03

24059DF02

UDI:

00196449016013

Recall #: Z-1223-2025; Quantity: 201 units

Product: A.L.P.S. mvX - MEDIAL TIBIA PLATE 12H RT (12-hole, Right)

Variants: 12-hole, Right

Model / REF:

770715122

Lot Numbers:

265817

24060DF08

263511

24057DF02

24057DF04

UDI:

00196449016020

Recall #: Z-1224-2025; Quantity: 208 units

Product: A.L.P.S. mvX - MEDIAL TIBIA PLATE 16H LT (16-hole, Left)

Variants: 16-hole, Left

Model / REF:

770715161

Lot Numbers:

24061DF01

24065DF02

24070DF01

UDI:

00196449016037

Recall #: Z-1225-2025; Quantity: 100 units

Product: A.L.P.S. mvX - MEDIAL TIBIA PLATE 16H RT (16-hole, Right)

Variants: 16-hole, Right

Model / REF:

770715162

Lot Numbers:

24053DF02

24070DF02

24057DF01

UDI:

00196449016044

Recall #: Z-1226-2025; Quantity: 109 units

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96212

Status: Active

Manufacturer: Tyber Medical

Sold By: authorized medical distributors

Manufactured In: United States

Distributed To: Nationwide