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
Reported: September 6, 2017 Initiated: August 4, 2017 #Z-3102-2017
Product Description
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
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.
Details
- Recalling Firm
- Encore Medical, Lp
- Units Affected
- 5 units
- Distribution
- OH, VA
- Location
- Austin, TX
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Encore Medical, Lp. Units affected: 5 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 6, 2017. Severity: Moderate. Recall number: Z-3102-2017.
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