Z-3102-2017 Class II Terminated
FDA device recall Z-3102-2017 was initiated by Encore Medical, Lp on Aug 4, 2017 and is designated Class II. 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… The recall status is terminated (terminated Jun 28, 2023). Affected quantity: 5 units.
Recall details
- Product Type
- Devices
- Report Date
- Sep 6, 2017
- Initiation Date
- Aug 4, 2017
- Termination Date
- Jun 28, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
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.
Distribution pattern
OH, VA
Code information
Catalog number, Lot Number S-200956, 535U1000 S-200957, 536U1000 S-200958, 537U1000
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3102-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026