Z-1036-2023Class II

OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of...

Name: Z-1036-2023 OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of...
Creator: Biomet, Inc.
Published: 2022-11-29
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2022-11-29 / Open, Classified / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, including midshaft... on 2022-11-29. FDA classified it as Class II and gives the reason as "Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement". 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-1036-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-29
Posted: 2023-01-27
Recalling firm: Zimmer GmbH
Product: OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee Item Number: CP260602
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement
Root cause tag: manufacturing process
FDA root cause: Process control
Action: ****UPDATE***Phase II Zimmer Biomet issued Urgent Medical Device Recall Letter (Removal) on March 7, via FedEx to the Distributor and Risk Manager. Letter states 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 recall 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. 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]. Zimmer Biomet is conducting the recall in a phased approach due to limited replacement products for the Modular Arthrodesis Nail Collar Assembly (PN: CP260602) and due to the ability to separately purchase the small locking collar bolts (PN: CP260603).Letter to Distributors via email on 11/29/22 states: Replacement Small Locking Collar Bolts (Part Number: CP260603) will be sent to your territory. Replacement orders were placed today, November 29, with overnight delivery to your main territory office (Phase 1) Once replacement devices are availab
Quantity in commerce: 2 units
Distribution: US Nationwide distribution in the states of CA, KY, FL.
Product codes and lots: UDI: (01)00880304082991(17)321103(10)136620 Lot Number: 136620

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1036-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1036-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-08	2023-01-27

Product code HSB

K042409Class IIModular Arthrodesis NailBiomet, Inc. / cleared 2004-12-02

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)