Recall Z-0650-2017 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Depuy Orthopaedics Inc.
ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed non-sterile, within a rigid tube with foam protectors, with label and IFU
| Date | Nov 21, 2016 (initiated Oct 25, 2016) |
| Status | Terminated |
| Reason | DePuy Orthopaedics, Inc. is issuing a voluntary recall for all lots of the ACTIS Flex Reamers due to the instruments breaking and potentially leaving pieces in the patient. |
| Root cause | Under Investigation by firm |
| Action | Depuy Orthopaedics initiated a recall on October 25, 2016. Notices were sent to the US Distributors via email on October 25, 2016. Customers were instructed to do the following: 1. Immediately Inspect Inventory, 2. Immediately Return US Distributor Inventory: If any affected instruments are found in a US Distributors inventory, return to: DePuy Synthes Joint Reconstruction, a division of DePuy Orthopaedics, Inc. 3. To expedite the return and credit process: Be sure to reference H16-14 on all return paperwork and/or online return forms and on the outside of the box when returning recalled lot |
| Quantity | 137 |
| Distribution | US Distribution to the states of: CA, KY, LA, MD, ME, NC, NH, NY, TX, VA, WA Foreign: Austria, Ireland, and Japan VA/DOD: |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150862 | DePuy Actis Duofox Hip Prosthesis DePuy Orthopaedics, Inc., Sep 25, 2015 |