| Date Initiated by Firm | March 07, 2018 |
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| Date Posted | March 20, 2018 |
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| Recall Status1 |
Terminated 3 on October 31, 2018 |
| Recall Number | Z-1317-2018 |
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| Recall Event ID |
79515 |
| 510(K)Number | K132296 |
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| Product Classification |
Screw, fixation, bone - Product Code HWC
|
| Product | D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD 2.4MM X 10MM S-T LOCKING SCREW, REF 74692410, QTY (1), STERILE R |
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| Code Information |
Lot Number 17GM04522 |
Recalling Firm/
Manufacturer |
Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
|
| For Additional Information Contact | David Snyder
978-749-1440 |
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Manufacturer Reason
for Recall | One lot of D-RAD Self-Taping Locking Screws used with the Distal Radius Fracture Kit were machined out of specification. Screws measured over tolerance within the head thread form by 0.002-0.003 inch. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | The firm initiated their recall by letter and email on 03/07/2018. The firm requested return of the product. |
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| Quantity in Commerce | 59 units |
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| Distribution | US, Puerto Rico, Malaysia |
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| Total Product Life Cycle | TPLC Device Report |
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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.
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| 510(K) Database | 510(K)s with Product Code = HWC
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