Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1122-2016·Announced 2016-03-23

Zimmer Manufacturing Recalls Distal Femoral Bone Fixation Appliances

Zimmer Manufacturing B.V. is recalling 37 sterile distal femoral bone fixation appliances due to insufficient sealer calibration data.

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, injuries, or hospitalizations. The hazard is related to packaging calibration data rather than a direct structural defect or contamination with reported harm, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Zimmer Manufacturing B.V. is recalling 37 units of sterile distal femoral bone fixation appliances. The affected products are identified by product code HRS and include specific item numbers for distal medial femoral and distal posterior/lateral components. These devices are metallic bone fixation appliances intended for implantation to fix fractures of the femur or for joint fusion.

The recall was initiated because of insufficient sealer calibration data for products packaged in the firm's Building II between August 2010 and April 2013. The source text does not specify the exact nature of the risk associated with the calibration data, but notes that the affected products are sterile.

The affected units were distributed nationwide in the United States. The recall number is Z-1122-2016. Consumers and healthcare providers should check their inventory for the specific lot numbers listed in the recall notice and contact the manufacturer for further instructions.

The recalled product

Product: Product 24 consists of all product under product code: HRS and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL MEDIAL FEMORAL CON 234703208 DISTAL MEDIAL FEMORAL CON 234800504 DISTAL POSTERIOR/LATERAL 234800506 DISTAL POSTERIOR/LATERAL…
Manufacturer: Zimmer Manufacturing B.V.
Category: Medical Device — Orthopedic Implants
Hazard: packaging-defect
sterility-compromise
Affected units: 37

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 72 recalled by Zimmer Manufacturing B.V. 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 72 products in this recall →

Same manufacturer · Zimmer Manufacturing B.V.

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Same hazard · packaging defect