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U.S. Department of Health and Human Services

Class 2 Device Recall RSP Impaction Fixture

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 Class 2 Device Recall RSP Impaction Fixturesee related information
Date Initiated by FirmFebruary 09, 2017
Create DateMarch 08, 2017
Recall Status1 Terminated 3 on October 20, 2017
Recall NumberZ-1413-2017
Recall Event ID 76456
Product Classification Impactor - Product Code HWA
ProductRSP 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 ContactDesiree Wells
512-832-9500
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
ActionThere 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 Commerce626 units
DistributionUS, South Korea, Australia, Canada, United Kingdom/Ireland, Germany
Total Product Life CycleTPLC 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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