FDA-Device2026-07-22Class IIPACKAGING DEFECT
Medline Total Knee Pack surgical kits recalled for sterility seal defects
Nationwide distributionMedical devices
What this means
Medline surgical kits containing Zimmer Biomet mixing bowls and spatulas have a seal defect that could compromise sterility. This defect could require surgeons to find an alternative device during a procedure. No injuries have been reported.
- If your facility received affected kits (Lots 26DMB644 or 26CMC467), do not use them.
- Contact Medline Industries for instructions on return or replacement.
- Check your inventory against the lot numbers listed in this recall.
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of CA and UT.
Affected count
163 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2736-2026More Medline recalls
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- FDA-Device2026-07-29Medline surgical convenience kits recalled for quality issues in anesthetic component
- FDA-Device2026-07-29Medline NEURO PACK medical kits recalled for Bacillus contamination
- FDA-Device2026-07-29Medline convenience kits with Bard Silastic Foley Catheters recalled for surface contamination
- FDA-Device2026-07-29Medline convenience kits with Bard Silastic Foley Catheters recalled for surface contamination
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