PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE, REF 71823114, QTY: (1) NON-STER
FDA device recall Z-2036-2017 · posted 2017-04-14 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc.
- Reason for recall
- This lot of left plates were laser etched and packaged as right plates.
- Action taken
- Smith & Nephew initiated their recall by email on March 22, 2017. Consignees are being requested to return all affected product in their possession. Distributors were instructed to notify their customers and ensure that the recall instructions were followed. For further questions, please call : 1(800) 821-5700.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 12 units
- Distribution
- Internationally to the country of : India
- Date initiated
- 2017-03-22
- Date posted
- 2017-04-14
- Date terminated
- 2022-06-03
- Location
- Memphis, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM (K092015) | Smith & Nephew, Inc. | 2009-07-30 |