Z-1403-2025Class II

Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder...

Name: Z-1403-2025 Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder...
Creator: Zimmer Orthopedics Manfacturing Limited-Galway
Published: 2025-03-03
License: https://open.fda.gov/license/

Zimmer Orthopedics Manufacturing Limited-Galway / initiated 2025-03-03 / Open, Classified / root cause: manufacturing process

FDA source

ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY began a recall of Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627 on 2025-03-03. FDA classified it as Class II and gives the reason as "Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the taper. Issue may lead to clinically significant extension...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1403-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-03
Posted: 2025-03-20
Recalling firm: Zimmer Orthopedics Manufacturing Limited-Galway
Product: Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627
Product code: MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Reason for recall: Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the taper. Issue may lead to clinically significant extension of surgery to find a replacement.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On March 3, 2025, the firm notified affected customers via Urgent Medical Device Recall letters. Customers were informed of the excess metal on the inner taper of the stem due to a chipped manufacturing tool. Customers were asked to notify all affected persons and assist their Zimmer Biomet sales representative in quarantining all affected product on hand. The products will be removed from your facility.
Quantity in commerce: 90 US; 136 OUS
Distribution: US distribution nationwide. International distribution to Dominican Republic, Canada, India, Australia, Japan, EMEA, Korea, Taiwan, and Hong Kong.
Product codes and lots: Item No. 113605, UDI-DI 00887868267550 Lots 66173214, 66173215; Item No. 113606, UDI-DI 00887868267567 Lots 66173216, 66173218, 66173219; Item No. 113607, UDI-DI 00887868267574 Lots 66173220, 66173221; Item No. 113627, UDI-DI 00887868267741 Lots 65901697, 65909480, 65915809

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1403-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1403-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-26	2025-03-20

Product code MBF

K193038Class IIComprehensive Shoulder SystemBiomet Manufacturing Corp / cleared 2020-10-28

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)