Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2217-2012·Announced 2012-08-22

DePuy Orthopaedics Recalls Unimplanted Custom Implant Devices

DePuy Orthopaedics is retrieving 8,338 custom implant devices that were ordered but not implanted, following an FDA Warning Letter.

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, which typically indicates a temporary or non-serious health risk. Since the devices have not been implanted and the recall is driven by a regulatory Warning Letter rather than reported injuries or deaths, it fits the Moderate category.

Plain-English summary

DePuy Orthopaedics, Inc. is recalling 8,338 custom implant devices. These devices are medical implants provided by prescription to meet specific patient needs and are exempt from FDA premarket review. The recall involves devices that surgeons may have ordered from DePuy Orthopaedics but have not yet implanted in patients.

The recall is being conducted in connection with a Warning Letter received from the U.S. Food and Drug Administration on December 9, 2011. The Warning Letter addressed issues regarding these custom device implants. The affected devices were distributed nationwide across the United States, including all 50 states, the District of Columbia, and Puerto Rico.

Surgeons and healthcare facilities that have ordered these devices should check their inventory for the specific part numbers listed in the recall notice. If any of these unimplanted devices are found, they should be removed from use and returned to DePuy Orthopaedics according to the instructions provided by the company.

The recalled product

Product: DePuy Custom Implant Devices Packaging: Packaging was not standardized on customs, it was dependant on the geometry of the product Product Usage: Description: Devices meeting the regulatory definition of a custom medical device are those which are provided by…
Manufacturer: DePuy Orthopaedics, Inc.
Category: Medical Device — Orthopaedic Implants
Hazard: regulatory-non-compliance
Affected units: 8,338

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 (20)

Part Number: 101178997
101201997
101201998
101201999
101214999
101402998
101402999
101403999
101436996
101436997
101466996
101466997
101467996
101467997
101467998
101468997
101468999
101469996
101469997
101470996

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

Same manufacturer · DePuy Orthopaedics, Inc.

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