The Recall Desk
ModerateFDA (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.

What this means for you

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
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 →

Related recalls

Same manufacturer · DePuy Orthopaedics, Inc.

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Same hazard · mechanical defect

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