The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0529-2013·Announced 2012-12-26

DePuy Mitek Sterile Reamers Recalled for Incorrect Size Labeling

DePuy Mitek is recalling 20 sterile reamers because 7 units were labeled as 11MM but contained 10MM reamers.

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, and the hazard is a minor labeling error (incorrect size) without reported injuries or illnesses, fitting the 'Moderate' criteria for low-risk contamination or labeling issues.

Plain-English summary

DePuy Mitek, Inc., a Johnson & Johnson Co., is recalling 20 units of DePuy Mitek 11 MM Fully Fluted Reamers, Sterile (Product Number: 232423, Lot Number: 3611687). The recall is due to incorrect labeling; specifically, 7 units were labeled as 11MM while the box actually contained a 10 MM reamer.

These sterile reamers are intended to cut through cortical and cancellous bone during Cruciate Ligament Repair/Reconstruction of the knee. The affected units were distributed nationwide, including Illinois and New Jersey.

Healthcare providers and consumers should stop using the affected units and contact DePuy Mitek for instructions on return or replacement.

The recalled product

Product
DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile Reamers are intended to cut through cortical and cancellous bone during Cruciate Ligament Repair/Reconstruction of the knee.
Manufacturer
DePuy Mitek, Inc., a Johnson & Johnson Co.
Category
Medical Device — Orthopedic Instrument
Hazard
Affected units
20

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: 3611687

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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