Recall Z-0943-2017 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
MicroPort Orthopedics Inc.
PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN Instruments support the implantation of implants. Broach handles mate to the broach to allow for preparation of the femoral canal for the stem component to be implanted. This
| Date | Jan 3, 2017 (initiated Nov 17, 2016) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 20 units |
| Distribution | Worldwide Distribution to Spain, China, and Italy |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012091 | PRO-FEMUR Wrightmedicaltechnologyinc, Oct 3, 2001 |