Recall Z-0941-2018 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Howmedica Osteonics Corp.
Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, 6276-5-216, 6020-2530, 6020-4535, 6021-0740, 6021-0230, and 6021-4535
| Date | Jul 21, 2017 |
| Status | Terminated |
| Reason | Inner and outer sterile barriers not fully sealed. |
| Root cause | Process control |
| Action | Recall notices were sent to customers with a request to return all affected product. |
| Quantity | 255 |
| Distribution | Distributed in ten (10) states: AR, DE, FL, IL, IN, MI, NJ, OH, TN, and TX; and Canada, Sweden, United Kingdom, France, Spain, Italy, Japan, Romania, Colombia, Netherlands, and Australia. |
| FDA record | Open on fda.gov |