Z-0674-2022Class II

Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM Long Item Number: 113631

Name: Z-0674-2022 Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM Long Item Number: 113631
Creator: Biomet, Inc.
Published: 2022-01-07
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2022-01-07 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM Long Item Number: 113631 on 2022-01-07. FDA classified it as Class II and gives the reason as "The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0674-2022
Classification: Class II
Status: Terminated
Initiated: 2022-01-07
Posted: 2022-02-24
Terminated: 2023-04-13
Recalling firm: Zimmer GmbH
Product: Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM Long Item Number: 113631
Product code: MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Reason for recall: The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Zimmer Biomet issued Urgent Medical Device Recall Letter (ZFA 2021-00267) to Distributors, Risk Managers, and Surgeons on January 7, 2022 via FedEx. For US and OUS distributors, the notification was completed via email . Letter states reason for recall, health risk and action to take: Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. If the product has been further distributed, provide your customers with the field safety notice for hospitals and ensure documentation. 4. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. This form shall be returned even if you do not have affected products at your facility. 5. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facility s documentation. 6. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected]. Surgeon Responsibilities: 1. Review this notification for awareness of the contents. 2. If the product has been implanted, Zimmer Biomet recommends assessing the patient with imaging and monitoring the patient for third body debris or loosening that could potentially contribute to the potential health risks. 3. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. 4. Retain a copy of the
Quantity in commerce: 11 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Ecuador, Netherlands.
Product codes and lots: Lot Number: 821860 UDI: (01)00880304462687(17) 290522(10)821860

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0674-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0670-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-02	2022-02-24
Z-0671-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-02	2022-02-24
Z-0672-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-02	2022-02-24
Z-0673-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-02	2022-02-24
Z-0674-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-02	2022-02-24
Z-0675-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-02	2022-02-24
Z-0676-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-02	2022-02-24
Z-0677-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-02	2022-02-24

Product code MBF

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)