—#104199

Product

Total Hip Joint Replacement Accolade TMZF Plus 127 Neck Angle V40 Hip Stem #3 Accolade TMZF Plus 127 Neck Angle V40 Hip Stem #5 Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 A subsidiary of Stryker Corp. Stryker France ZAC Satolos Green Pusignan Av de Staolas Green 69881 Metziae Cedex France The TMZF Press Fit HA Stem and TMZF Press Fit Plus HA Stem are intended for the reconstruction of the head and neck of the femoral joint. The device is intended for primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty. These stems can be used with any currently available Howmedica Osteonics acetabular components and V40 Femoral Heads that can be mated with a 5 40 BG taper.

FDA product code: MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K994366
Affected lot / code info: K994366 6021-0335 6021-0537 Accolade TMZF Plus 127 Neck Angle V40 Hip Stem #3; Catalog #6021-0335 Lot Code 35427003; Accolade TMZF Plus 127 Neck Angle V40 Hip Stem #5; Catalog #6021-0537 Lot Code 35202601

Why it was recalled

Stryker Orthopaedics has become aware that a size 3 Accolade stem was in a box labeled as a size 5 Accolade stem.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

Stryker Orthopaedics sent an "URGENT: PRODUCT RECALL" letter dated July 14, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to complete and return an attached Product Recall Acknowledgment Form via fax to 201-831-6069. Additionally, information is provided for customers to return the affected products. Please contact the Divisional Regulatory Compliance Manager at 201-972-2100 for questions regarding this notice.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Drive, Mahwah, New Jersey 07430

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2011-07-14
Posted by FDA: 2011-10-20
Terminated: 2013-11-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #104199. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.