Various LactoSorb System Implants (2020-10-30)
- Starting date:
- October 30, 2020
- Posting date:
- December 11, 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-74509
Last updated:
2020-12-10
Affected Products
A. LACTOSORB TRAUMA PLATING SYSTEM 1.5 & 2.0 MM
B. LACTOSORB FLOOR PLATE
Reason
Zimmer Biomet is conducting a lot specific Medical Device Recall for various LactoSorb System Implants due to potential presence of elevated bacterial endotoxin levels that exceed the specification limit for products subject to compression molding/machining manufacturing workflow that were cleaned between January 12, 2020 and July 22, 2020.
Affected products
A. LACTOSORB TRAUMA PLATING SYSTEM 1.5 & 2.0 MM
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
More than 10 numbers, contact manufacturer.
Companies
- Manufacturer
-
Biomet Microfixation also trading as Walter Lorenz Surgical Inc.
1520 Tradeport Drive
Jacksonville
32218
Florida
UNITED STATES
B. LACTOSORB FLOOR PLATE
Lot or serial number
774980
774990
Model or catalog number
915-2808
Companies
- Manufacturer
-
Biomet Microfixation also trading as Walter Lorenz Surgical Inc.
1520 Tradeport Drive
Jacksonville
32218
Florida
UNITED STATES