Profemur(r) R Rasp Handle recall
PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN Instruments support the implantation of implants.…
Why was Profemur(r) R Rasp Handle recalled?
The recall is being initiated because all broach handles in the affected lot had the same non-conformity with the connection feature. The broach handles may have machining issues that do not allow the handle to properly mate with an associated broach.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number US100122
- Product
- PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN Instruments support the implantation of implants.…
- Recalling firm
- MicroPort Orthopedics Inc.
- Quantity
- 20 units
- Distribution
- Worldwide Distribution to Spain, China, and Italy
- Recall date
- January 11, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)