—#209479

Product

Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;

FDA product code: JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K023087, K222056
Affected lot / code info: Catalog Number: C-MM100434-00; Lot Number: HX2H9A;

Why it was recalled

A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.

Root cause (FDA determination)

Process control

Action the firm took

On August 5, 2024 an URGENT MEDICAL DEVICE RECALL letter was sent to their consignee. Actions Needed: Our records indicate that you have received the affected product, and that product has already been returned to Stryker. We therefore request that you read this notice carefully and complete the following actions. 1. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form. Please assist us in meeting our regulatory obligation by emailing back the attached Urgent Medical Device Recall Business Reply Form within 5 days. We regret any inconvenience this action may cause. For questions pertaining to the recall, please email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com

Recalling firm

Firm: Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2006

Distribution

Distribution pattern: International distribution to the country of Australia.

Timeline

Recall initiated: 2024-08-05
Posted by FDA: 2024-08-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209479. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.