—#206543

Product

stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty

FDA product code: HSN — Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K123954
Affected lot / code info: UDI/DI 00889797004008, Lot Numbers: 2656950, 2762126, 2796094

Why it was recalled

Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustment Blocks. The parts within these three lots were found to have been missing an internal screw in the finished instrument assembly. The missing screw is used to lockout the Medial/Lateral adjustment on the INFINITY Resection Adjustment Guide.

Root cause (FDA determination)

Process change control

Action the firm took

Stryker issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 03/06/2024 via email. The notice explained the issue, potential risk, and requested the consignee isolate/quarantine the affected product pending return of the device. If the affected product was further distributed, please notify the applicable parties at once about this recall. This notification letter may be copied and distributed. a. If possible, inform Stryker if any of the subject devices have been distributed to other organizations, including contact details so that we can inform the recipients appropriately. b. If you are a distributor, note that you are responsible for notifying your affected customers. For questions or concerns, please contact memphis.fieldaction@stryker.com.

Recalling firm

Firm: Wright Medical Technology, Inc.
Address: 1023 Cherry Rd, Memphis, Tennessee 38117-5423

Distribution

Distribution pattern: US: TX, NE, and AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, FRANCE, GERMANY, ITALY, SPAIN, SWEDEN, SWITZERLAND, UK

Timeline

Recall initiated: 2024-03-06
Posted by FDA: 2024-04-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #206543. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.