Z-1543-2020Class II

Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 -

Name: Z-1543-2020 Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 -
Creator: Biomet, Inc.
Published: 2020-02-17
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2020-02-17 / Terminated

FDA source

Biomet, Inc. began a recall of Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the comprehensive humeral stem mini is to act as... on 2020-02-17. FDA classified it as Class II and gives the reason as "A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1543-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-17
Posted: 2020-03-03
Terminated: 2022-05-31
Recalling firm: Zimmer GmbH
Product: Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the comprehensive humeral stem mini is to act as the humeral component of the comprehensive total shoulder system.
Product code: MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Reason for recall: A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem.
FDA root cause: Under Investigation by firm
Action: URGENT MEDICAL DEVICE FIELD SAFETY NOTICE-REMOVAL letter dated February 17, 2020 was sent via email to consignees. The letter identified affected product, problem and the action to be taken. Customers were advised to take the following actions: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 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 Certification of Acknowledgement Form and send to [email protected] form must be returned even if you do not have affected products available to return in your facility. 5.Retain a copy of the acknowledgement form with your field action records in the event of a compliance audit of your facilitys documentation. 6. If you have further questions or concerns after reviewing this notice, please contact your Zimmer Biomet representative. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA: Med Watch Reporting: Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs Med Watch Adverse Event Reporting program either online, by mail, or by fax. Online: www.fda.gov/medwatch/report.htm Mail: Use postage paid, pre-addressed form FDA 3500, available at: www.fda.gov/MedWatch/getforms.htm Fax: 1-800-FDA-0178 Under 21 CFR 803, manufacturers are required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Zimmer Biomet informed of any adverse events associated with this product or any other Zimmer Biomet product by emailing [email protected].
Quantity in commerce: 14 units
Distribution: International distribution in the countries of Canada, Japan, Netherlands, South Korea.
Product codes and lots: Lot No. 659260, UDI Number: (1)00880304462649(17)290814(10)659260

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1543-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1543-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-20

Product code MBF

K060692Class IIComprehensive Primary Shoulder StemsBiomet Manufacturing Corp / cleared 2006-05-30

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)