Comprehensive Segmental Revision System (SRS)/Discovery Distal Body with Screw 50mm-70mm (2018-03-13)
- Starting date:
- March 13, 2018
- Posting date:
- March 23, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-66274
Affected products
Comprehensive Segmental Revision System (SRS)/Discovery Distal Body with Screw 50mm-70mm
Reason
Zimmer Biomet is conducting a recall of specific lots of the comprehensive Segmental Revision System (SRS)/discovery distal body with screw. Zimmer Biomet has received reports that during assembly, an SRS humeral distal body implant failed to engage correctly at the point of reduction with a discovery elbow system humeral condyle. A mismatch occurred between the screw holes in the distal humeral body and the discovery elbow condyle implant during vendor machine operation. The mismatch does not always prevent engagement of the screw and the condition would be noticed during assembly.
Affected products
Comprehensive Segmental Revision System (SRS)/Discovery Distal Body with Screw 50mm-70mm
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
211250
211251
211252
211253
211254
211255
Companies
- Manufacturer
-
Biomet Orthopedics
56 East Bell Drive
Warsaw
46581
Indiana
UNITED STATES