Medline Total Knee Pack recalled for seal defects risking sterility breach
What this means
Medline kits containing Zimmer Biomet mixing bowls and spatulas have seal defects that could compromise sterility during knee replacement surgery. The issue may require surgeons to obtain replacement equipment during the procedure, but no patient injuries have been reported.
- If you received or used kit lot 26DME172 (UDI-DI 10195327388447), contact your surgical facility or Medline for guidance.
- Do not use affected kits for sterile procedures.
- Check with your hospital or surgery center about whether you were affected.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2737-2026More Medline recalls
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