Howmedica Osteonics Corp.: Triathlon Knee System Inserts Recalled for Sterile Packaging Breaches

Agency Publication Date: March 6, 2024

Summary

Approximately 441 units of Howmedica Osteonics (Stryker) X3 Triathlon and TS Plus knee system inserts are being recalled because the sterile packaging may have breaches or holes in the inner and outer blister packs. These medical devices are used in orthopedic knee replacement surgeries and were distributed across the United States and several foreign countries. While no specific injury reports are mentioned in the data, a breach in sterile packaging for an implantable device can introduce contaminants directly into a surgical site.

Risk

A breach in the sterile packaging of an implantable device compromises its sterility, which can lead to serious surgical site infections or other complications for the patient during or after knee replacement surgery.

What You Should Do

Locate the product packaging for any X3 Triathlon CS or TS Plus Tibial inserts and check the Part Number, GTIN, and Lot Number printed on the label.
Check for X3 TRIATHLON CS INSERT NO 3 10 MM (Part 5531-G-310-E, GTIN 07613327390544) with Lot Numbers 313JA9, 8711AV, A4462V, XD1AT4, MR77W5, TD5KL3, H97AME, or YW30KL.
Check for X3 TRIATHLON CS INSERT NO 6 10 MM (Part 5531-G-610-E, GTIN 07613327390575) with Lot Numbers 1L0WAY, 323EAY, A72D9D, 9885E1, 9Y397R, or L573YP.
Check for TRIATHLON TS PLUS TIB INS X3 (Parts 5537-G-311-E, 5537-G-411-E, 5537-G-416-E, 5537-G-513-E) with Lot Numbers EP81Y7, YL5VKA, E97TH6, H21A0K, XY776E, 9M3A91, or EV0DV0.
Immediately quarantine any affected products to ensure they are not used in surgical procedures.
Contact your healthcare provider or Howmedica Osteonics Corp. (Stryker) at 325 Corporate Dr, Mahwah, NJ for specific instructions on returning the affected products and obtaining replacements.
For further information or questions regarding this recall, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Quarantine and return product

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

Affected Products

Product: X3 TRIATHLON CS INSERT NO 3 10 MM

Model / REF:

5531-G-310-E

UPC Codes:

07613327390544

Lot Numbers:

313JA9

8711AV

A4462V

XD1AT4

MR77W5

TD5KL3

H97AME

YW30KL

Date Ranges: Expiration Date: 10/07/2028

Product: X3 TRIATHLON CS INSERT NO 6 10 MM

Model / REF:

5531-G-610-E

UPC Codes:

07613327390575

Lot Numbers:

1L0WAY

323EAY

A72D9D

9885E1

9Y397R

L573YP

Date Ranges: Expiration Date: 10/07/2028

Product: X3 TRIATHLON CS INSERT NO 6 11 MM

Model / REF:

5531-G-611-E

UPC Codes:

07613327337341

Lot Numbers:

HL7228

Date Ranges: Expiration Date: 11/08/2028

Product: X3 TRIATHLON CS INSERT NO 7 9 MM

Model / REF:

5531-G-709-E

UPC Codes:

07613327337464

Lot Numbers:

KA1Y71

Date Ranges: Expiration Date: 11/08/2028

Product: NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM

Model / REF:

5537-G-311-E

UPC Codes:

07613327288063

Lot Numbers:

EP81Y7

YL5VKA

Date Ranges: Expiration Date: 10/07/2028

Product: NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM

Model / REF:

5537-G-411-E

UPC Codes:

07613327287691

Lot Numbers:

E97TH6

Date Ranges: Expiration Date: 10/07/2028

Product: NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM

Model / REF:

5537-G-416-E

UPC Codes:

07613327287745

Lot Numbers:

H21A0K

XY776E

Date Ranges: Expiration Date: 10/07/2028

Product: NO 5 TRIATHLON TS PLUS TIB INS X3 POLY 13 MM

Model / REF:

5537-G-513-E

UPC Codes:

07613327287813

Lot Numbers:

9M3A91

EV0DV0

Date Ranges: Expiration Date: 10/07/2028

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94026

Status: Active

Manufacturer: Howmedica Osteonics Corp.

Sold By: Direct distribution to hospitals and surgical centers

Manufactured In: United States

Units Affected: 8 products (132 units (US); 26 units (OUS); 143 units (US); 24 units (US); 24 units (US); 39 units (US); 10 units (OUS); 18 units (US); 5 units (OUS); 24 units (US); 1 unit (OUS); 37 units (US); 10 units (OUS))

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

Locate the product packaging for any X3 Triathlon CS or TS Plus Tibial inserts and check the Part Number, GTIN, and Lot Number printed on the label.

Check for X3 TRIATHLON CS INSERT NO 3 10 MM (Part 5531-G-310-E, GTIN 07613327390544) with Lot Numbers 313JA9, 8711AV, A4462V, XD1AT4, MR77W5, TD5KL3, H97AME, or YW30KL.

Check for X3 TRIATHLON CS INSERT NO 6 10 MM (Part 5531-G-610-E, GTIN 07613327390575) with Lot Numbers 1L0WAY, 323EAY, A72D9D, 9885E1, 9Y397R, or L573YP.

Check for TRIATHLON TS PLUS TIB INS X3 (Parts 5537-G-311-E, 5537-G-411-E, 5537-G-416-E, 5537-G-513-E) with Lot Numbers EP81Y7, YL5VKA, E97TH6, H21A0K, XY776E, 9M3A91, or EV0DV0.

Immediately quarantine any affected products to ensure they are not used in surgical procedures.

Contact your healthcare provider or Howmedica Osteonics Corp. (Stryker) at 325 Corporate Dr, Mahwah, NJ for specific instructions on returning the affected products and obtaining replacements.

For further information or questions regarding this recall, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: X3 TRIATHLON CS INSERT NO 3 10 MM

Model / REF:

5531-G-310-E

UPC Codes:

07613327390544

Lot Numbers:

313JA9

8711AV

A4462V

XD1AT4

MR77W5

TD5KL3

H97AME

YW30KL

Date Ranges: Expiration Date: 10/07/2028

Product: X3 TRIATHLON CS INSERT NO 6 10 MM

Model / REF:

5531-G-610-E

UPC Codes:

07613327390575

Lot Numbers:

1L0WAY

323EAY

A72D9D

9885E1

9Y397R

L573YP

Date Ranges: Expiration Date: 10/07/2028

Product: X3 TRIATHLON CS INSERT NO 6 11 MM

Model / REF:

5531-G-611-E

UPC Codes:

07613327337341

Lot Numbers:

HL7228

Date Ranges: Expiration Date: 11/08/2028

Product: X3 TRIATHLON CS INSERT NO 7 9 MM

Model / REF:

5531-G-709-E

UPC Codes:

07613327337464

Lot Numbers:

KA1Y71

Date Ranges: Expiration Date: 11/08/2028

Product: NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM

Model / REF:

5537-G-311-E

UPC Codes:

07613327288063

Lot Numbers:

EP81Y7

YL5VKA

Date Ranges: Expiration Date: 10/07/2028

Product: NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM

Model / REF:

5537-G-411-E

UPC Codes:

07613327287691

Lot Numbers:

E97TH6

Date Ranges: Expiration Date: 10/07/2028

Product: NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM

Model / REF:

5537-G-416-E

UPC Codes:

07613327287745

Lot Numbers:

H21A0K

XY776E

Date Ranges: Expiration Date: 10/07/2028

Product: NO 5 TRIATHLON TS PLUS TIB INS X3 POLY 13 MM

Model / REF:

5537-G-513-E

UPC Codes:

07613327287813

Lot Numbers:

9M3A91

EV0DV0

Date Ranges: Expiration Date: 10/07/2028

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94026

Status: Active

Manufacturer: Howmedica Osteonics Corp.

Sold By: Direct distribution to hospitals and surgical centers

Manufactured In: United States

Distributed To: Nationwide