Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers:
FDA device recall Z-0372-2016 · posted 2015-12-04 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc.
- Reason for recall
- The devices were packaged and laser marked anatomically incorrect. The Left plates were laser marked and packaged as Right plates and the Right plates were laser marked and packaged as Left plates.
- Action taken
- Distributors, notified by Fed- Ex on 10/20/2015, were asked to quarantine the product and return it.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 9 units
- Distribution
- International only Germany, Japan, Russia
- Date initiated
- 2015-10-20
- Date posted
- 2015-12-04
- Date terminated
- 2016-09-21
- Location
- Memphis, TN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PERI-LOC BONE PLATING AND SCREW SYSTEM (K083032) | Smith & Nephew, Inc. | 2009-01-07 |