Z-1960-2019Class II

Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509

Name: Z-1960-2019 Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509
Creator: Zimmer Biomet, Inc.
Published: 2019-06-10
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2019-06-10 / Terminated / root cause: sterility

FDA source

Zimmer Biomet, Inc. began a recall of Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509 on 2019-06-10. FDA classified it as Class II and gives the reason as "Lack of an adequate sterilization validation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1960-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-10
Posted: 2019-07-12
Terminated: 2020-09-10
Recalling firm: Zimmer GmbH
Product: Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509
Product code: FSM Tray, Surgical, Instrument
Reason for recall: Lack of an adequate sterilization validation.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: Medical Device Recall notification letters dated 6/10/19 were sent to customers.
Quantity in commerce: 92
Distribution: The products were distributed US nationwide. The products were distributed to the following foreign countries: Argentina, Australia, Canada, Chile, China, Columbia, Costa Rica, Ecuador, India, Japan, Korea, Malaysia, Mexico, Netherlands, Thailand, Venezuela.
Product codes and lots: Lots: 262549 266083 1441011 M642860 2881015 3021022 3081051 266083 2591050 2771027 3231028 MJ54320 MJ54330 MJ54350 MJ54340

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1960-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1960-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-24	2019-07-12
Z-1961-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-24	2019-07-12

Product code FSM

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)