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U.S. Department of Health and Human Services

Class 2 Device Recall Turon Glenoid Reamer

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 Class 2 Device Recall Turon Glenoid Reamersee related information
Date Initiated by FirmAugust 04, 2017
Create DateAugust 31, 2017
Recall Status1 Terminated 3 on June 28, 2023
Recall NumberZ-3102-2017
Recall Event ID 77930
Product Classification Reamer - Product Code HTO
ProductMODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN, SIZE 46 REF S-200957 - 5mm PIN, SIZE 50 REF S-200958 - 5mm PIN, SIZE 58
Code Information Catalog number, Lot Number S-200956, 535U1000 S-200957, 536U1000 S-200958, 537U1000  
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information Contact
512-832-9500
Manufacturer Reason
for Recall		It was reported that the models used to manufacture S-200956/958 had the wrong dimension used to create the spherical radius cutting surface. Device design allows a larger spherical radius cutting surface than intended.
FDA Determined
Cause 2		Employee error
ActionThe firm initiated their recall by telephone and email to their sales representatives and surgeons on 08/04/2017. The letter explained the problem and advised the surgeons that the sales representative would be collecting the devices for return.
Quantity in Commerce5 units
DistributionOH, VA
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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