Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0169-2019·Announced 2018-10-24

Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defect

Zimmer Biomet is recalling 20 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses or injuries, and the hazard is a packaging defect rather than a high-risk pathogen or structural failure.

Plain-English summary

Zimmer Biomet, Inc. is recalling 20 units of the Affixus Hip Fracture Nail 125 9 mm x 165 mm (Item Number 816709165). The recall was initiated after complaints indicated that the sterile packaging was already open when the product was opened in surgery. The product is intended for the fixation of fractures.

The affected units, identified by Lot Number 694950, were distributed worldwide. In the United States, they were distributed in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY. The products were also distributed to Chile and the Netherlands.

This is an FDA Class II recall. The source text does not report any illnesses or injuries associated with the defect. Healthcare providers should stop using the affected units and contact Zimmer Biomet for instructions on return or replacement.

The recalled product

Product: Affixus Hip Fracture Nail 125 9 mm x 165 mm, Item Number 816709165 Product Usage: Intended for the fixation of fractures
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: packaging-defect
sterility-compromise
Affected units: 20

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Lot Numbers: 694950

Distribution

Distributed nationwide across the United States.

The notice also names 41 states specifically:

Part of a larger recall action

This product is one of 48 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 48 products in this recall →

Same manufacturer · Zimmer Biomet, Inc.

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Same hazard · packaging defect