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Affixus recallZ-0969-2026 · Zimmer, Inc. · initiated Dec 2, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process design

What the company is doing

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.

Recall details

Recall number
Z-0969-2026
Status
Open, Classified
Initiated by the company
Dec 2, 2025
Posted by the FDA
Dec 22, 2025
Recalling firm
Zimmer, Inc.
Quantity
22
Product code
HSB
FDA submissions
K241651
Distribution
US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.

Product description

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 mm, Right, Trochanteric Nail Component: N/A

Code information (models, lots, serial numbers)

Lot Code: Model No 815509360 ; UDI-DI (01)00887868143540(17)340917(10)66717553 ; Lot Number 66717553 Model No 815509360 ; UDI-DI (01)00887868143540(17)340823(10)66884563 ; Lot Number 66884563

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

16 devices cleared under K241651 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 98069).

Sources and updates

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