—#83194

Product

V 40 Femoral Head, Sterile, 22 mm; Catalog number 6260-4-122, Catalog number 6260-5-226; Howmedica Osteonics Corp., Stryker Ireland, Carrigtwohill County Cork, Ireland; Intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty.

FDA product code: LWJ — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K022077, K993601
Affected lot / code info: lot # 29213701;Exp. 1/28/2014 and lot # 29228301; Exp 1/28/2014

Why it was recalled

Sterilization issue: During post-sterilization inspection of the outer blister packaging of the affected lots, it was determined that the outer blister did not meet the required minimum seal width.

Root cause (FDA determination)

Process control

Action the firm took

Urgent Product Recall letters were sent via Federal Express on June 18, 2009 to all Stryker Branches/Agencies, hospital Risk Management, hospital Chief of Orthopaedics and surgeons who may have used the recalled products. The letters stated the issue, potential hazards, and the risk mitigation. Customers may contact Colleen O'Meara at 201-831-5970 with any questions.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2009-06-18
Posted by FDA: 2009-08-18
Terminated: 2012-08-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #83194. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.