Z-1131-2021Class II

Central Screw 6.5x25mm -

Name: Z-1131-2021 Central Screw 6.5x25mm -
Creator: Biomet, Inc.
Published: 2021-01-15
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2021-01-15 / Terminated / root cause: labeling and UDI

FDA source

Biomet, Inc. began a recall of Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation on 2021-01-15. FDA classified it as Class II and gives the reason as "Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation that a 40 MM length central...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1131-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-15
Posted: 2021-02-17
Terminated: 2023-03-09
Recalling firm: Zimmer GmbH
Product: Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation.
Product code: PHX Shoulder Prosthesis, Reverse Configuration
Reason for recall: Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation that a 40 MM length central screw was packaged and labeled as a 25 MM length central screw.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On 01/19/2019, Zimmer Biomet issued Urgent Medical Device Recall notices to distributors with direct sales and/or fielded inventory via email and traceable letter sent via FedEx. Hospitals with direct sales or current inventory will be notified via FedEx. Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation that a 40 MM length central screw was packaged and labeled as a 25 MM length central screw.
Quantity in commerce: 49
Distribution: US Nationwide distribution including in the states of MS, MN, KY, FL, MI, OH, AZ, IL, WI, CA, UT, TN.
Product codes and lots: Model No.: 115395, Lot No.: 077170, UDI: (01) 00880304677074 (17) 301010 (10) 077170

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1131-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1131-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-24	2021-02-17

Product code PHX

K132239Class IIComprehensive Reverse Shoulder ScrewsBiomet Manufacturing Corp / cleared 2013-09-06

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)