Z-0973-2026Class II

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails...

Name: Z-0973-2026 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails...
Creator: Zimmer, Inc.
Published: 2025-12-02
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2025-12-02 / Open, Classified / root cause: manufacturing process

FDA source

Zimmer, Inc. began a recall of Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509440 Software Version: N/A... on 2025-12-02. FDA classified it as Class II and gives the reason as "Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue...". 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-0973-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-02
Posted: 2025-12-22
Recalling firm: Zimmer GmbH
Product: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 mm, Right, Trochanteric Nail Component: N/A
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Firm began notifying customers on December 2, 2025 via Urgent Medical Device Recall letters. Distributors are to locate and quarantine affected product in their inventory. They must also return all affected product from their distributorship and from affected hospitals within their territory. Risk Managers are to assist Zimmer Biomet sales representatives in quarantining all affected product. Sales representatives will remove the product from customer facilities. Surgeons are to maintain awareness of the issue, but there are no patient-monitoring instructions related to this recall recommended beyond their existing follow-up schedules.
Quantity in commerce: 22
Distribution: US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.
Product codes and lots: Lot Code: Model No 815509440 ; UDI-DI (01)00887868143588(17)340820(10)66717557 ; Lot Number 66717557 Model No 815509440 ; UDI-DI (01)00887868143588(17)350422(10)67101279 ; Lot Number 67101279 Model No 815509440 ; UDI-DI (01)00887868143588(17)350419(10)67101280 ; Lot Number 67101280

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0973-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0967-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-22
Z-0968-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-22
Z-0969-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-22
Z-0970-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-22
Z-0971-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-22
Z-0972-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-22
Z-0973-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-22
Z-0974-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-22
Z-0975-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-22
Z-0976-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-22
Z-0977-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-22
Z-0978-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-22
Z-0979-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-22
Z-0980-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-22
Z-0981-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-22
Z-0982-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-22
Z-0983-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-22

Product code HSB

K241651Class IIAffixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc. / cleared 2024-09-26

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)