—#118702

Product

R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE H2O2, REF 71335760. Orthopaedic.

FDA product code: MBL — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K113848
Affected lot / code info: Batch No. 12FM00602

Why it was recalled

One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and packaged as a 60 mm 20o liner.

Root cause (FDA determination)

Packaging process control

Action the firm took

All affected Smith & Nephew Sales Representatives were notified of problem and the recall via email on 5/29. They were instructed to cease use and distribution of the product and quarantine for return. Surgeons were notified by letter beginning on 6/12. International consignees were notified on 05/29 via email.

Recalling firm

Firm: Smith & Nephew Inc
Address: 1450 E. Brooks Rd, Memphis, Tennessee 38116

Distribution

Distribution pattern: Worldwide Distribution-USA including the states of PA, WA, TX, FL, IA, MI, WI, TN, KY, IN, NY, MO and OR, and the countries of India, Canada, Chile, Venezuela, Dubai, South Africa, Australia, Poland, Romania, Belgium, Germany and United Kingdom.

Timeline

Recall initiated: 2013-05-29
Posted by FDA: 2013-08-08
Terminated: 2016-03-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #118702. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.