| Date Initiated by Firm | March 22, 2017 |
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| Date Posted | April 14, 2017 |
|---|
| Recall Status1 |
Terminated 3 on June 03, 2022 |
| Recall Number | Z-2036-2017 |
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| Recall Event ID |
76934 |
| 510(K)Number | K092015 |
|---|
| Product Classification |
Plate, fixation, bone - Product Code HRS
|
| Product | PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE, REF 71823114, QTY: (1) NON-STERILE, Rx only, Smith & nephew, Inc., Memphis TN 38116 |
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| Code Information |
Lot 16DM15958 |
Recalling Firm/
Manufacturer |
Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
|
Manufacturer Reason
for Recall | This lot of left plates were laser etched and packaged as right plates. |
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FDA Determined
Cause 2 | Mixed-up of materials/components |
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| Action | 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. |
|---|
| Quantity in Commerce | 12 units |
|---|
| Distribution | Internationally to the country of : India |
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| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = HRS
|
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