Z-2233-2021Class II

Medline Total Knee, convenience kit, REF DYNJ907129B, containing expired component NaCl 3000mL Irrigation Bag...

Name: Z-2233-2021 Medline Total Knee, convenience kit, REF DYNJ907129B, containing expired component NaCl 3000mL Irrigation Bag...
Creator: Medline Industries Inc
Published: 2021-07-01
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2021-07-01 / Terminated / root cause: manufacturing process

FDA source

Medline Industries Inc began a recall of Medline Total Knee, convenience kit, REF DYNJ907129B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020) on 2021-07-01. FDA classified it as Class II and gives the reason as "The kits may contain an expired component". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2233-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-01
Posted: 2021-08-09
Terminated: 2023-03-02
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline Total Knee, convenience kit, REF DYNJ907129B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
Product code: OJH Orthopedic Tray
Reason for recall: The kits may contain an expired component.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Consignees were notified by letter dated and issued on 7/1/2021 via first class mail. The letter informed the consignee the convenience kits were being recalled due to the irrigation bag expiring August 21,2020. The consignee was to immediately check their stock for the affected kit and kit lot number and affix the enclosed sticker on the kit which instructs the consignee to remove the expired irrigation bag and replace it with sterile product from their supply. The remainder of the components may be used.
Quantity in commerce: 286 total kits for all products
Distribution: US Nationwide distribution in the states of MN, NE, and PA.
Product codes and lots: Lot 20LBF040, Exp. 2021-12-31, GTIN (01)10193489443615.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2233-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2231-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-09
Z-2232-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-09
Z-2233-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-09
Z-2234-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-09

Product code OJH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)