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Class 2 Device Recall RSP Impaction Fixture |
 |
| Date Initiated by Firm |
February 09, 2017 |
| Create Date |
March 08, 2017 |
| Recall Status1 |
Terminated 3 on October 20, 2017 |
| Recall Number |
Z-1413-2017 |
| Recall Event ID |
76456 |
| Product Classification |
Impactor - Product Code HWA
|
| Product |
RSP Impaction Fixture |
| Code Information |
109931L01, 109931L02, 115670L15, 115670L16, 128092L08, 128092L09, 137917L16, 167829L06, 52258L01, 52258L01A, 67428L01, 76386L01, 76386L02, 81722L01, 81722L02 |
Recalling Firm/
Manufacturer |
Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758-5445
|
| For Additional Information Contact |
Desiree Wells
512-832-9500
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Manufacturer Reason
for Recall |
During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating.
|
FDA Determined
Cause 2 |
Device Design |
| Action |
There are two field safety notices, one for Consignees who have surgeons that use the impaction fixtures (Verson 1) and one for Consignees who had previously indicated their surgeons do NOT use the impaction fixtures (Verson 2). The two recall notification letters were sent out on 2/9/17. |
| Quantity in Commerce |
626 units |
| Distribution |
US, South Korea, Australia, Canada, United Kingdom/Ireland, Germany |
| 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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