Z-1961-2019Class II

Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510

Name: Z-1961-2019 Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510
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 Total (Outer Case Vault Only), Item Number 595510 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-1961-2019
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 Total (Outer Case Vault Only), Item Number 595510
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: 1257
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: 251059 254986 203752 260646 263012 264753 2111048 2111052 2111050 2111051 21110107 21110106 21110117 2291017 2881019 3231032 2981046 3341019 831129 1961120 21110105 21110108 1961120 1961120 1961120 3461146 1961120 1961120 1961120 1961120 1961120 3461146 1081211 1081211 1081211 1951228 1951228 1951228 1951228 1951228 3181203 3181203 3181203 3181203 1411303 1411303¿ 1411303 1721312 1721312 1721312 2631353 2631353 3461146 MB33730 171421 1721312 ME50120 ME50130 1641404 MH50820 1641404 1641404 2331407 1721312 1961120 2291016 3461146 2331407 2331407 ML35700 2331407 2631048 ML56520 2331407 2331407 2331407 2331407 961509 961509 961509 961509 MO93600 MO93610 961509 961509 1631512 1631512 2261523 2261523 2261523 2681520 2681520 2681520 443894 2681520 443894 443894 476977 476977 501920 501920 530934 538816

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1961-2019
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)