Vanguard Knee System & RingLoc Hip System (2020-04-15)
- Starting date:
- April 15, 2020
- Posting date:
- May 1, 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-72939
Last updated: 2020-05-01
Affected Products
A. Vanguard Knee System, Series-A Standard Patella, 28 MM
B. Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral
C. RingLoc Hip System, Acetabular Liner, 36 MM, Size 26
D. Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, A6
E. Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard
Reason
Zimmer Biomet is conducting a lot specific medical device recall for various polyethylene. In February 2017, Zimmer Biomet initiated a medical device recall for specific lots of various polyethylene implants. We recently discovered additional affected lots that may be in your inventory. The affected products are being removed due to the potential presence of elevated endotoxin levels that exceed the specification limit. The issue was discovered during routine bacterial endotoxin testing (BET). There have been no complaints received related to the additional affected lots.
Endotoxins (pyrogens) are substances found in certain bacteria. The FDA-adopted standard for endotoxin levels is 20 EU/device. There were three polyethylene implant samples during an approximate 6-week period that were found to exceed this level. As a result, certain polyethylene implants manufactured between December 2016 and January 2017 are being removed. Affected products that have the potential to exceed process limits for endotoxins could present potential risks.
Affected products
A. Vanguard Knee System, Series-A Standard Patella, 28 MM
Lot or serial number
- 508390
Model or catalog number
- 184762
Companies
- Manufacturer
-
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES
B. Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral
Lot or serial number
- 548700
- 548720
- 630710
- 697350
Model or catalog number
- US154705
- US154722
- US154727
- US154731
Companies
- Manufacturer
-
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES
C. RingLoc Hip System, Acetabular Liner, 36 MM, Size 26
Lot or serial number
- 588500
Model or catalog number
- XL-105916
Companies
- Manufacturer
-
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES
D. Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, A6
Lot or serial number
- 630740
Model or catalog number
- US154745
Companies
- Manufacturer
-
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES
E. Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard
Lot or serial number
- 502510
Model or catalog number
- XL-115366
Companies
- Manufacturer
-
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES