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U.S. Department of Health and Human Services

Class 2 Device Recall Turon Impaction Fixture

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  Class 2 Device Recall Turon Impaction Fixture see related information
Date Initiated by Firm February 09, 2017
Create Date March 08, 2017
Recall Status1 Terminated 3 on October 20, 2017
Recall Number Z-1412-2017
Recall Event ID 76456
Product Classification Impactor - Product Code HWA
Product Turon Impaction Fixture
Code Information 101521L01, 115670L18, 128092L10, 136172L07, 136172L08, 141511L22, 37369L10A, 37369L10B, 37837L23A, 37837L23B, 37837L23C, 37837L23D, 51103L05E, 51103L05F, 52748L02A, 52748L02B, 52748L02C, 52748L02D, 52748L02E, 52748L02F, 52748L02G, 52748L02H, 57074L05A, 89910L10
Recalling Firm/
Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information Contact Desiree Wells
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 297 units
Distribution US, South Korea, Australia, Canada, United Kingdom/Ireland, Germany
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.