PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN Instruments support t
FDA device recall Z-0943-2017 · posted 2017-01-03 · Terminated
Recall details
- Recalling firm
- MicroPort Orthopedics Inc.
- Reason for recall
- 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.
- Action taken
- MicroPort Orthopedics sent an Voluntary Device Product Recall letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return the enclosed form even if they do not have any affected product to return. Return the completed form by fax to 1-901-451-6032 or by email to PostMarket@ortho.microport.com. Attempt #1 for acknowledgment will be made by email. For questions regarding this recall call 901-867-4318.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LZO
- Quantity affected
- 20 units
- Distribution
- Worldwide Distribution to Spain, China, and Italy
- Date initiated
- 2016-11-17
- Date posted
- 2017-01-03
- Date terminated
- 2018-08-18
- Location
- Arlington, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRO-FEMUR (K012091) | Wrightmedicaltechnologyinc | 2001-10-03 |