—#88560

Product

Howmedica Restoration ADM Trial Cup Holder; Non Sterile; Benoist Girard, Cedex, France; Distributed by Howmedica Osteonics Corp. Mahwah, NJ. The intended use: The Restoration ADM Window Trial is locked onto the Restoration ADM Trial Cup Holder and placed into the acetabulum to evaluate the size and congruity of the preparation for visualization and assessment of fit, contact and congruency of the trial within the acetabulum.

FDA product code: MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: Catalog number: 1235-0-000; Lot number: G2546019

Why it was recalled

The Restoration ADM Trial Cup Holder may not have been assembled correctly.

Root cause (FDA determination)

Other

Action the firm took

An "URGENT PRODUCTION OPERATION" letter dated January 21, 2010, was sent to customers via FedEx. The letter described the product, problem and actions to be taken by customer. The customers should follow the instructions on the enclosed PRODUCT BULLETIN. The customer should check their internal inventory immediately and quarantine all affected devices, identify if the device is correctly assembled and complete the Product Correction Acknowledgement Form and fax it to (201) 831-6069. If you have any questions, feel free to contact Rich Wolyn, Manager, Divisional Regulatory Reporting at (201) 831-5158.

Recalling firm

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

Distribution

Distribution pattern: Nationwide distribution: AZ, CA and OR

Timeline

Recall initiated: 2010-01-21
Posted by FDA: 2010-04-19
Terminated: 2012-06-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #88560. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.