Official recall notice
FDA DeviceClass IINotable
FDA Recall: Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK-LF DYNJ61651J
- Recall date
- 2026-07-22
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.
Product description
Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.
Affected products
UDI-DI 10195327388447 Kit Lot 26DME172