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Class 2 Device Recall Turon Glenoid Reamer |
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| Date Initiated by Firm |
August 04, 2017 |
| Create Date |
August 31, 2017 |
| Recall Status1 |
Terminated 3 on June 28, 2023 |
| 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
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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
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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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