Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2083-2014·Announced 2014-07-30

DePuy Orthopaedics Recalls RECLAIM Distal Tapered Surgical Instruments

DePuy Orthopaedics is recalling RECLAIM Distal Tapered surgical instruments because they can be difficult to remove from the Distal Stem.

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 involves a functional difficulty in removing the instrument rather than a direct risk of serious injury or death.

Plain-English summary

DePuy Orthopaedics, Inc. is recalling the RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes, and Taper Protector Sleeve. These are orthopedic manual surgical instruments used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

The recall is due to a defect where the product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming. The recall involves 10,467 units distributed worldwide, including the United States and various international locations.

Healthcare providers and consumers should stop using the affected products and contact DePuy Orthopaedics for further instructions on returns or replacements.

The recalled product

Product: RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
Manufacturer: DePuy Orthopaedics, Inc.
Category: Medical Device — Orthopedic Surgical Instrument
Hazard: mechanical-defect
Affected units: 10,467

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)

Product # 197714190
Lot # 107342
107343
107346
107347
138357
138358
138359
138360
138361
138362
138363
163354
163356
163357
190780
190783
190784
211757
211758

Distribution

Distributed in 49 states:

Part of a larger recall action

This product is one of 3 recalled by DePuy Orthopaedics, Inc. 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 3 products in this recall →

Same manufacturer · DePuy Orthopaedics, Inc.

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Same hazard · mechanical defect