Multiple Sterile Zimmer Biomet Products (2020-12-02)
- Starting date:
- December 2, 2020
- Posting date:
- December 18, 2020
- 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-74551
Last updated:
2020-12-18
Affected Products
A. RingLoc+ Quick Connect Drill Bit
B. Orthopedic Salvage System (OSS) Tibial Bushing ArCom
C. Comprehensive Reverse Shoulder Central Screw
D. Comprehensive Reverse Shoulder Fixed Locking Screw
E. Comprehensive Reverse Shoulder Non-Locking Screw
Reason
Zimmer Biomet is conducting a lot specific medical device recall for multiple sterile Zimmer Biomet products due to the potential for a breach in the sterile seal. A breach in the packaging seal could potentially lead to loss of sterility of the device. Based on an inspection of the affected packaging, a breach in the sterile seal is estimated to occur in less than 0.5% of the affected product.
Affected products
A. RingLoc+ Quick Connect Drill Bit
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
31-323215
31-323220
31-323230
31-323240
Companies
- Manufacturer
-
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES
B. Orthopedic Salvage System (OSS) Tibial Bushing ArCom
Lot or serial number
59680
Model or catalog number
150476
Companies
- Manufacturer
-
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES
C. Comprehensive Reverse Shoulder Central Screw
Lot or serial number
208000
214760
270260
484060
Model or catalog number
115394
115395
Companies
- Manufacturer
-
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES
D. Comprehensive Reverse Shoulder Fixed Locking Screw
Lot or serial number
214650
272680
354120
376710
497970
498690
498800
498880
Model or catalog number
180550
180552
180553
180554
180555
Companies
- Manufacturer
-
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES
E. Comprehensive Reverse Shoulder Non-Locking Screw
Lot or serial number
214740
353240
353300
Model or catalog number
180559
180560
Companies
- Manufacturer
-
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES