DePuy ReClaim Reamer Extension Recalled Due to Broken Tabs
DePuy Orthopaedics is recalling 750 ReClaim Reamer Extension devices because tabs may break and remain in patients during surgery.
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 risk of harm (foreign object retention) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 750 units of the ReClaim Reamer Extension (Product code 2975-00-500). This device is an attachment used with the Reclaim Modular Revision Hip Prosthesis System to allow surgeons to clear soft tissue while reaming the distal femoral canal. The recall is due to reports that the tabs on the reamer extension device have broken.
The affected devices were distributed worldwide, including in the United States and various international locations. DePuy is notifying surgeons to increase awareness of the issue and to inspect the devices for broken tabs before and after surgery. This action is intended to reduce the potential for broken tabs to be left in the patient.
Once the root cause is determined and a design change is implemented, DePuy will conduct a formal swap-out of the affected devices. Surgeons and users are advised to look for tabs before and after surgery to ensure safety.
The recalled product
- Product
- ReClaim Reamer Extension; Product code 2975-00-500, used with Reclaim Modular Revision Hip Prosthesis System. The ReClaim Reamer Extension is as an attachment to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal.
- Manufacturer
- DePuy Orthopaedics, Inc.
- Affected units
- 750
Distribution
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