| Date Initiated by Firm | January 07, 2019 |
|---|
| Create Date | January 12, 2019 |
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| Recall Status1 |
Terminated 3 on September 17, 2020 |
| Recall Number | Z-0730-2019 |
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| Recall Event ID |
81917 |
| 510(K)Number | K123598 |
|---|
| Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
|
| Product | SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613 |
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| Code Information |
Lot Numbers: C63165, C63306, C63495 |
Recalling Firm/
Manufacturer |
Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
|
Manufacturer Reason
for Recall | The pin that holds the spring mechanism is not properly mounted. The pin could potentially disassemble. |
|---|
FDA Determined
Cause 2 | Process control |
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| Action | The firm initiated the recall by email and letter on 01/07/2019. The firm requested the return of the product. |
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| Quantity in Commerce | 72 units |
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| Distribution | NY, TN, Germany, Italy, Great Britain, Singapore |
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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.
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| 510(K) Database | 510(K)s with Product Code = LXH
|
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