DePuy Orthopaedics Recalls RECLAIM Distal Reamer Extension Devices
DePuy Orthopaedics is recalling 875 units of RECLAIM Distal Reamer Extension devices because the tabs may break and leave fragments in the patient.
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 3/5 (High).
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 risk-of-harm product (foreign body fragments in a patient) where the source text does not explicitly report that injuries or illnesses have already occurred, fitting the criteria for a High severity score.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 875 units of the RECLAIM Distal Reamer Extension (REF 2975-00-500). This non-sterile medical device is intended as an attachment to distal reamers to help surgeons clear soft tissue while reaming the distal femoral canal.
The recall is being conducted because the tabs on the device have the potential to break, which could leave fragments in the patient. The affected units were distributed worldwide, including in the United States and various international locations such as Canada, Australia, and several European and South American countries.
Healthcare providers and facilities that have received these specific lots should stop using the devices and contact DePuy Orthopaedics for further instructions on the recall process.
The recalled product
- Product
- RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment device to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal.
- Manufacturer
- DePuy Orthopaedics, Inc.
- Affected units
- 875
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)
- J0111
- J0211
- J0411
- J0611
- J0911
- J1211
- NB12649
- NB12650
- NB12651
- NB12652
- NB12653
- NB12654
- NB12655
- NB12656
- NB23480
- NB23481
- NB3584
- NB3586
- NB3587
- NB3588
Distribution
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