Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1123-2016·Announced 2016-03-23

Zimmer Manufacturing Recalls Distal Femoral Components for Sterility Concerns

Zimmer Manufacturing B.V. is recalling specific distal femoral components used in total hip arthroplasty 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 hospitalizations, injuries, or illnesses. The hazard is a potential sterility issue due to calibration data, which fits the criteria for a moderate, precautionary recall.

Plain-English summary

Zimmer Manufacturing B.V. is recalling specific distal femoral components used in total hip arthroplasty. The affected products are sterile and were packaged in the firm's Building II between August 2010 and April 2013. The recall is being conducted because of insufficient sealer calibration data for these items.

The recall covers product under product code LPH, including item numbers 234703104, 234703206, 234703208, 234800504, 234800506, 234800508, 234800510, 234800604, 234800606, 234800608, 234800610, and 234800614. The specific lot numbers involved are 62233575 and 62255244. The products were distributed nationwide in the United States.

Healthcare providers and patients should check their inventory or medical records to determine if they have these specific components. If the products are identified, they should be removed from use and returned to the manufacturer or disposed of according to the firm's instructions.

The recalled product

Product: Product 25 consists of all product under product code: LPH 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 234800508…
Manufacturer: Zimmer Manufacturing B.V.
Category: Medical Device — Orthopedic Implant
Hazard: sterility
calibration-error
Affected units: 2

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 no.: 62233575 62255244

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 · sterility