Recall Z-3102-2017— Encore Medical, Lp
Class II · Terminated
Class II FDA medical device recall by Encore Medical, Lp, initiated 2017-08-04, terminated 2023-06-28. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: 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..
- Recalling firm
- Encore Medical, Lp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-08-04
- Terminated
- 2023-06-28
- Firm location
- Austin, TX, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.