Trabecular Metal Tibial Augment Block (2019-02-07)
- Starting date:
- February 7, 2019
- Posting date:
- March 1, 2019
- 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-69176
Affected Products
Trabecular Metal Tibial Augment Block
Reason
An investigation determined that potential co-mingling, resulting in the product in the box potentially not matching the product on the label.
The package says NexGen Complete Knee Solution Trabecular Metal Tibial Half Block Augment Right Lateral/Left Medial w/screws size 4 5mm thickness (PN: 00-5448-004-26) on the label however the product inside is NexGen Complete Knee Solution Trabecular Metal Tibial Half Block Augment Left Lateral/Right Medial w/screws size 4 5mm thickness (PN: 00-5448-004-36).
Affected products
Trabecular Metal Tibial Augment Block
Lot or serial number
63257915
Model or catalog number
00-5448-004-26
Companies
- Manufacturer
-
Zimmer Trabecular Metal Technology Inc.
10 Pomeroy Road
Parsippany
New Jersey
UNITED STATES