The Recall Desk
ModerateFDA (Devices)·Z-2084-2014·Announced 2014-07-30

DePuy RECLAIM Taper Protector Sleeve Recalled for Removal Difficulty

DePuy Orthopaedics is recalling RECLAIM Taper Protector Sleeves 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 device rather than a direct risk of serious injury or death, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

DePuy Orthopaedics, Inc. is recalling the RECLAIM DISTAL TAPERED Distal Stem Taper Protector Sleeve. The recall involves 3,623 units distributed worldwide, including the United States and various international markets.

The product is being recalled because it can be difficult to remove from the Distal Stem both out of the package and after proximal reaming. This instrument is used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

No specific instructions for consumers are provided in the source text, as this is a medical device recall managed through the FDA. Healthcare providers and facilities should check their inventory for the affected lot numbers listed in the official recall notice.

The recalled product

Product
RECLAIM DISTAL TAPERED 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 Instrument
Hazard
Affected units
3,623

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 # 197614140
  • Lot # 107310
  • 107311
  • 107313
  • 107314
  • 107315
  • 136244
  • 136247
  • 136251
  • 136252
  • 136256
  • 136257
  • 136262
  • 136268
  • 136271
  • 136276
  • 136286
  • 196221
  • 196222
  • 196225

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 · device removal difficulty

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