FDA Medical Device Recalls (openFDA)
Howmedica Osteonics Corp.: Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon Tritanium Tibial Component (Size 5); Catalog Number 5536-B-500
- Recall number
- Z-1237-2022
- Recalling firm
- Howmedica Osteonics Corp.
- Product
- Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon Tritanium Tibial Component (Size 5); Catalog Number 5536-B-500
- Status
- Open, Classified
- Initiated
- 2022-03-30
- Posted
- 2022-06-03
- Terminated
- not on file
- Reason
- Stryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial Component inside the package does not match the package labeling.
- Root cause
- Under Investigation by firm
- Action
- On March 30, 2022, the firm sent Urgent Medical Device Recall letters to affected customers. Customers were instructed to immediately identify, quarantine, and discontinue use of any affected devices in their facility. Customers should return the devices back to Stryker. If you have any questions or concerns regarding this recall, please contact Customer Service at (201) 831-5000. For questions pertaining to the recall, email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com. ***Updated 6/6/22*** On June 6, 2022, the firm sent an updated letter to affected customers. The update letter includes the hazards, harms, and risk mitigation.
- Quantity
- 22 units (12 US; 10 OUS)
- Distribution
- Worldwide distribution - US Nationwide in the states of AL, CA, CO, ID, IN, KS, MI, NV, PA, TN, WA, and WV. The countries of UK and Poland.
- Lot, serial or model codes
- Catalog Number UDI-DI (GTIN) Lots 5536-B-600 07613327041514 CTD69463 5536-B-500 07613327041507 CTD69106
- 510(k) numbers
- ["K123486"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28