Agency classClass IIOur severity:Severe FDA (Devices)·Z-3172-2018·Announced 2018-09-19

Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

Zimmer Biomet is recalling 5,947 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls involving significant injury or structural defects in medical devices are categorized as Severe (Score 4).

Plain-English summary

Zimmer Biomet, Inc. is recalling 5,947 units of the Affixus Hip Fracture Nail Left 130° 13 mm x 440 mm (Item Number: 814613440). The recall is due to a defect where the set screw is unable to advance or reverse from the original position in the nail.

The affected products were distributed to 38 US states and Puerto Rico, as well as to Chile, Ecuador, Japan, and the Netherlands. The specific distribution states include AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WY.

Healthcare providers and patients should contact Zimmer Biomet for instructions on how to manage the affected devices. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 440 mm, Item Number: 814613440
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: mechanical-failure
set-screw-defect
Affected units: 5,947

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)

157490 482830

Distribution

Distributed in 42 states:

Part of a larger recall action

This product is one of 129 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 129 products in this recall →

Same manufacturer · Zimmer Biomet, Inc.

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Same hazard · mechanical failure