Compress Device Centering Sleeve, Compress Device and Compress Device Short Anti-Rotation Spindle, Anti-Rotation Elliptical Spindle, and Compress Instrument Drill for Anti-Rotation Pin (2018-12-13)
- Starting date:
- December 13, 2018
- Posting date:
- January 9, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-68652
Affected products
- Compress Device Centering Sleeve
- Compress Device Anti-Rotation Spindle
- Compress Device Anti-Rotation Elliptical Spindle
- Compress Device Short Anti-Rotation Spindle
- Compress Device Short Anti-Rotation Elliptical Spindle
- Compress Instrument Drill for Anti-Rotation Pin
Reason
Zimmer Biomet is expanding a previous medical device notification, dated October 22, 2018, in order to update the pin placement tables on page 42 and page 45 of the compress and mini compress surgical techniques, respectively, regarding which array to use in the placement of the anti-rotation pins. These updates were made due to the potential for interference between the centering sleeves and anti-rotation drill when using certain spindle and centering sleeve combinations. Additional item numbers are included in the updated notice to users.
Affected products
A. Compress Device Centering Sleeve
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
178537
178538
178541
178542
178544
178545
Companies
- Manufacturer
-
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
UNITED STATES
B. Compress Device Anti-Rotation Spindle
Lot or serial number
046290
097130
292790
602000
921610
Model or catalog number
178351
178352
178354
178355
178357
178358
Companies
- Manufacturer
-
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
UNITED STATES
C. Compress Device Anti-Rotation Elliptical Spindle
Lot or serial number
282760
Model or catalog number
178360
178361
Companies
- Manufacturer
-
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
UNITED STATES
D. Compress Device Short Anti-Rotation Spindle
Lot or serial number
115070
Model or catalog number
178362
178363
178364
178365
178366
178367
178368
178369
178370
Companies
- Manufacturer
-
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
UNITED STATES
E. Compress Device Short Anti-Rotation Elliptical Spindle
Lot or serial number
All
Model or catalog number
178371
178372
178373
Companies
- Manufacturer
-
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
UNITED STATES
F. Compress Instrument Drill for Anti-Rotation Pin
Lot or serial number
All
Model or catalog number
32-481123
Companies
- Manufacturer
-
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
UNITED STATES