R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762. Orthopaedi
FDA device recall Z-1928-2013 · posted 2013-08-08 · Terminated
Recall details
- Recalling firm
- Smith & Nephew Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- MBL
- Quantity affected
- 53 units
- Distribution
- 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,
- Date initiated
- 2013-05-29
- Date posted
- 2013-08-08
- Date terminated
- 2016-03-22
- Location
- Memphis, TN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| R3 XLPE LINERS (K113848) | Smith & Nephew, Inc. | 2012-04-27 |