Compress Device Centering Sleeve, Anti-Rotation Spindle, Anti-Rotation Elliptical Spindle, and Compress Instrument Drill for Anti-Rotation Pin (2018-10-22)
- Starting date:
- October 22, 2018
- Posting date:
- November 2, 2018
- 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-68168
Affected products
- Compress Device Centering Sleeve
- Compress Device Anti-Rotation Spindle
- Compress Device Anti-Rotation Elliptical Spindle
- Compress Instrument Drill for Anti-Rotation Pin
Reason
Zimmer Biomet is conducting a medical device correction to update the surgical technique for the compress system. Users should be aware that changes were made to the selection criteria section (pin placement table) on page 42 regarding which array to use in the placement of the anti-rotation pins. The updated pin placement table ensures that the selection criteria for the spindle and centering sleeves will not interfere with the anti-rotation drill or pin. There is no replacement or modification to the product offered.
Affected products
A. Compress Device Centering Sleeve
Lot or serial number
- 285210
- 285220
- 609510
- 694130
- 694150
- 784180
- 809100
- 809130
- 830530
- 831000
Model or catalog number
- 178537
- 178541
- 178542
- 178544
- 178545
- 178738
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
- 602000
- 921610
Model or catalog number
- 178350
- 178353
- 178356
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
178359
Companies
- Manufacturer
-
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
UNITED STATES
D. Compress Instrument Drill for Anti-Rotation Pin
Lot or serial number
All lots
Model or catalog number
32-481123
Companies
- Manufacturer
-
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
UNITED STATES