Z-0803-2018Class II

The 2nd Assist Knee Positioner

Name: Z-0803-2018 The 2nd Assist Knee Positioner
Creator: Zimmer Biomet, Inc.
Published: 2017-09-07
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-09-07 / Terminated / root cause: packaging

FDA source

Zimmer Biomet, Inc. began a recall of The 2nd Assist Knee Positioner on 2017-09-07. FDA classified it as Class II and gives the reason as "Zimmer Biomet is conducting a medical device recall for the 2nd Assistant Knee Positioner due to the potential for the sterile packaging barrier to be breached during distribution". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0803-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-07
Posted: 2018-02-28
Terminated: 2018-08-23
Recalling firm: Zimmer GmbH
Product: The 2nd Assist Knee Positioner
Product code: JEB Table, Surgical With Orthopedic Accessories, Manual
Reason for recall: Zimmer Biomet is conducting a medical device recall for the 2nd Assistant Knee Positioner due to the potential for the sterile packaging barrier to be breached during distribution.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: On September 12, 2017 an URGENT MEDICAL DEVICE RECALL notice was issued to distributors and customers titled "The Second Assistant Disposable Knee Positioner". The notice requests customers to review their inventory and to quarantine any remaining product, which will be returned to the firm. Also, to notify any additional accounts which may have received product from you. Questions or concerns can be directed to Customer Service at 574-371-3071
Quantity in commerce: 38,879 units
Distribution: Nationally
Product codes and lots: Item# 740026

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0803-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0803-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-28

Product code JEB

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