Agency classClass IIOur severity:High FDA (Devices)·Z-1793-2021·Announced 2021-06-09

Zimmer Femoral Nail Recall: Risk of Commingled Angle Versions

Zimmer is recalling 16 units of its Natural Nail femoral implant due to potential commingling between two versions with different CCD angles (130 and 125 degrees). Wrong angle components could result in improper fracture fixation.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall involving potential commingling of orthopedic implant components with different CCD angles. While this represents a significant risk of harm—improper implant angle could result in poor fracture fixation or bone misalignment—no injuries or illnesses have been reported in the source text. Per the rubric, recalls with theoretical hazards and no reported injuries are scored at most 3.

Plain-English summary

Zimmer GmbH is recalling 16 units of the Natural Nail (ZNN) Cephalomedullary Short Nail, a medical device intended for temporary fracture fixation and bone stabilization. The affected device (item number 47-2493-213-11) is made from titanium alloy and measures 11.5 mm by 21.5 cm with a CCD (center-to-center distance) angle of 130 degrees.

The recall is due to potential commingling of components between the 130-degree and 125-degree CCD angle versions of this nail. If the wrong angle version is implanted during surgery, it could result in improper fracture fixation or bone misalignment.

The affected lot (3025629) was distributed to healthcare facilities in California, Georgia, Kentucky, and Maryland, as well as to Australia, Brazil, Canada, and the Netherlands. This is an FDA Class II recall.

Patients or healthcare providers should contact Zimmer GmbH if they have questions about whether they have received or implanted any units from this lot.

The recalled product

Product: Zimmer Natural Nail- ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 130 CCD Left Ti-6Al-4V Alloy-is intended for temporary fracture fixation and stabilization of the bone Item Number: 47-2493-213-11
Manufacturer: Zimmer GmbH
Category: Medical Device — Orthopedic / Femoral Nail
Hazard: commingling
wrong-angle
misalignment
Affected units: 16

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 Number: 3025629 UDI: (01) 0088902498965 (17) 300131 (10) 3025629

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 2 recalled by Zimmer GmbH 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 2 products in this recall →

Same manufacturer · Zimmer GmbH

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Same hazard · commingling