Z-2736-2026Class II

Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267

Name: Z-2736-2026 Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267
Creator: Medline Industries, LP
Published: 2026-06-10
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-06-10 / Open, Classified / root cause: sterility

FDA source

Medline Industries, LP began a recall of Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267 on 2026-06-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2736-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-10
Posted: 2026-07-15
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267
Product code: LRO General Surgery Tray
Reason for recall: 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.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: On June 10, 2026, the firm began notifying customers via First-Class Mail and email. Customers were instructed to request stickers to over-label the affected convenience kits with a label indicating to remove the affected component and replace it with product from supply. No kits are to be returned.
Quantity in commerce: 163 kits
Distribution: US Nationwide distribution in the states of CA and UT.
Product codes and lots: UDI-DI 10198459538827 Kit Lots 26DMB644 26CMC467

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2736-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2736-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-15
Z-2737-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-15

Product code LRO

K213481Class IIMedline General Surgery TrayMedline Industries, Inc. / cleared 2022-05-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)