Reflection, Microstable Acetabular Liner, REF 71740250, 32mm ID, 50-52 OD, 1 each, sterile EO. Component is a liner used
FDA device recall Z-1004-2009 · posted 2009-04-21 · Terminated
Recall details
- Recalling firm
- Smith & Nephew Inc
- Reason for recall
- Liners measuring 28 mm ID and were mismarked as 32 mm.
- Action taken
- All affected Smith & Nephew International Distributors were notified via e-mail dated November 24, 2008. In a letter titled "Urgent: Product Recall Notice - Immediate Action Required", distributors were instructed to immediately notify their accounts concerning the recall. All affected product is to be located and returned to the firm immediately. Direct questions to Smith & Nephew, Inc. by calling 1-901-399-5441.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LPH
- Quantity affected
- 19 units
- Distribution
- International Distribution to Canada, France, Germany and Switzerland.
- Date initiated
- 2008-11-21
- Date posted
- 2009-04-21
- Date terminated
- 2011-11-21
- Location
- Memphis, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS (K991026) | Smith & Nephew, Inc. | 1999-10-22 |