| Date Initiated by Firm | April 08, 2016 |
|---|
| Create Date | May 25, 2016 |
|---|
| Recall Status1 |
Terminated 3 on December 05, 2016 |
| Recall Number | Z-1711-2016 |
|---|
| Recall Event ID |
73870 |
| 510(K)Number | K110598 |
|---|
| Product Classification |
Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
|
| Product | SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement. |
|---|
| Code Information |
Lot numbers: 1390763, 14AA094, 14AA431, 14AA528, 15AA094, 15AA557, 15AA558, 15AA559, 15AA600 |
| FEI Number |
3008021110
|
Recalling Firm/
Manufacturer |
Limacorporate S.p.A
Via Nazionale 52
San Daniele Del Friuli Italy
|
Manufacturer Reason
for Recall | Complaints of intra-operative breakage of the glenosphere impactors/extractors. |
|---|
FDA Determined
Cause 2 | Component design/selection |
|---|
| Action | The affected firms received written notification to all distributors. The letter instructed the consignee to identify and remove all affected product in stock and return parts to Lima USA. |
|---|
| Quantity in Commerce | 314 units |
|---|
| Distribution | Distributed US (nationwide) and in Australia. |
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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 = KWS
|
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