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Medium RiskFDA Device
Medical Devices

Zimmer, Inc.: Distal Lateral Fibular Locking Plates Recalled for Thread Form Issues

Agency Publication Date: April 30, 2024
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Summary

Zimmer, Inc. has recalled several versions of its ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plates because the locking holes may have improper thread forms. This defect means that locking screws may not correctly mate or lock with the plate during surgery. If the screw does not lock properly, it can lead to surgical delays or a loss of bone fixation, potentially requiring further medical intervention or surgery to correct the issue.

Risk

An improperly mated screw may not be immediately recognizable to the surgeon during a procedure. This failure to lock can result in the internal stabilization of the fracture failing, leading to a loss of fixation and the need for additional surgeries to repair the bone.

What You Should Do

  1. Identify if you have any ZPLP Distal Lateral Fibular Plates by checking the Item Numbers (such as 47-2357-017-04 or 00-2357-017-06) and Lot Numbers found on the product packaging.
  2. For sterile products, cross-reference your package with UDI numbers such as (01)00889024088498(17)321205(10)65620069 or (01)00889024088504(17)330115(10)65703586.
  3. For non-sterile products, check the GTIN barcodes on the labels, including 00889024055865, 00889024055872, 00889024055889, 00889024055896, 00889024055902, 00889024055919, 00889024055926, and 00889024055933.
  4. Healthcare providers should immediately stop using affected plates and sequester them from their inventory to prevent use in future surgeries.
  5. Contact Zimmer, Inc. at 1-800-123-4567 (or your local representative) to arrange for the return of affected inventory and to receive further instructions regarding potential replacements or credits.
  6. Patients who have recently undergone surgery involving a fibular locking plate and are experiencing unusual pain or instability should contact their orthopedic surgeon or healthcare provider.
  7. For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Inventory Quarantine and Notification

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund.

Affected Products

Product: ZPLP Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Sterile
Model / REF:
47-2357-017-04
UPC Codes:
00889024088498
Lot Numbers:
65620069
65635922
65635923
65674071
65674072
66010704
66166096
66216633
Product: ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Sterile
Model / REF:
47-2357-017-06
UPC Codes:
00889024088504
Lot Numbers:
65703586
65703587
66247618
66247619
Product: ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Sterile
Model / REF:
47-2357-017-08
UPC Codes:
00889024088511
Lot Numbers:
64811254
64811255
65834885
Product: ZPLP Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Sterile
Model / REF:
47-2357-017-10
UPC Codes:
00889024088528
Lot Numbers:
66060712
Product: ZPLP Distal Lateral Fibular Plate, Right, 12 Holes, 184 MM, Sterile
Model / REF:
47-2357-017-12
UPC Codes:
00889024088535
Lot Numbers:
64475610
65038408
65038409
65209412
65209413
Product: ZPLP Distal Lateral Fibular Plate, Right, 16 Holes, 236 MM, Sterile
Model / REF:
47-2357-017-16
UPC Codes:
00889024088559
Lot Numbers:
64475611
64475612
Product: ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Sterile
Model / REF:
7-2357-018-04
UPC Codes:
00889024088566
Lot Numbers:
64325922
64325923
64396817
64396818
64464677
64714915
64714916
64714917
65324701
65387353
65716463
65716464
65982902
66010705
Product: ZPLP Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Sterile
Model / REF:
47-2357-018-06
UPC Codes:
00889024088573
Lot Numbers:
64370380
64370382
64423329
64475643
64661551
64661552
64745739
64745742
64745744
64745745
65635924
65645147
65755766
65997131
65997134
66023658
66166098
66201200
66233083
66233084
Product: ZPLP Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Sterile
Model / REF:
47-2357-018-08
UPC Codes:
00889024088580
Lot Numbers:
64568169
64697763
64697764
65755769
65782566
65782567
66233085
Product: ZPLP Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Sterile
Model / REF:
47-2357-018-10
UPC Codes:
00889024088597
Lot Numbers:
65588868
65943457
66034781
Product: ZPLP Distal Lateral Fibular Plate, Left, 12 Holes, 184 MM, Sterile
Model / REF:
47-2357-018-12
UPC Codes:
00889024088603
Lot Numbers:
64381071
65038410
65038411
65038412
65193244
65233124
65233125
Product: ZPLP Distal Lateral Fibular Plate, Left, 14 Holes, 210 MM, Sterile
Model / REF:
47-2357-018-14
UPC Codes:
00889024088610
Lot Numbers:
64381072
64661553
Product: ZPLP Distal Lateral Fibular Plate, Left, 16 Holes, 236 MM, Sterile
Model / REF:
47-2357-018-16
UPC Codes:
00889024088627
Lot Numbers:
64464711
66010706
Product: ZPLP Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Nonsterile
Model / REF:
00-2357-017-04
UPC Codes:
00889024055865
Lot Numbers (333):
64370265
64370266
64370267
64370268
64370269
64370270
64370271
64370279
64370280
64370281
64370289
64370290
64370291
64370292
64370293
64370299
64370301
64370303
64370305
64370307
64475227
64475228
64475252
64475276
64475298
64475306
64475320
64475324
64475359
64475360
64475379
64475383
64528443
64528464
64528481
64528482
64528483
64528484
64528485
64528486
64528487
64528488
64528489
64528490
64528491
64528492
64528493
64528494
64528495
64552845

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94276
Status: Active
Manufacturer: Zimmer, Inc.
Sold By: authorized medical distributors; hospitals; surgical centers
Manufactured In: United States
Distributed To: Nationwide

Were You Affected by This Recall?

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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 ยท 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.