DePuy RECLAIM Taper Protector Sleeve Recalled for Removal Difficulty
DePuy Orthopaedics is recalling 814 RECLAIM Taper Protector Sleeves because the product can be difficult to remove from the Distal Stem.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect that could impact surgical safety, but no injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 814 units of the RECLAIM Taper Protector Sleeve, an orthopedic manual surgical instrument used to protect the locking taper surface of the Distal Stem 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 affected units were distributed worldwide, including in the United States and various international markets. The recall covers specific product and lot numbers identified by the manufacturer. No specific illnesses or injuries are reported in the source text, but the difficulty in removing the instrument presents a potential risk during surgical procedures.
Healthcare providers and consumers should stop using the affected RECLAIM Taper Protector Sleeves and contact DePuy Orthopaedics for further instructions on how to return or replace the product.
The recalled product
- Product
- RECLAIM 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.
- Affected units
- 814
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 (12)
- Product # 297500110 Lot # 126559
- 126569
- 181990
- 181995
- 224156
- 231487
- 240683
- 260366
- 260370
- 272820
- 272827
- 272831 & 272836.
Distribution
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.
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