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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 Reamer see related information
Date Initiated by Firm August 04, 2017
Create Date August 31, 2017
Recall Status1 Completed
Recall Number Z-3102-2017
Recall Event ID 77930
Product Classification Reamer - Product Code HTO
Product MODIFIED/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
Action The 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 Commerce 5 units
Distribution OH, VA
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.
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