Recall Z-1692-2020 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Encore Medical, LP
djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trials with Spring Sides, Lateral, nonsterile, REF S-200636. The firm name on the label is djosurgical, Austin, TX.
| Date | Jul 10, 2018 |
| Status | Open, Classified |
| Reason | The retaining ring on the neck trials has a potential to fail interoperatively. |
| Root cause | Process design |
| Action | The recalling firm issued a letter dated 7/10/2018 to their field representatives (agencies) via email explaining the reason for recall. |
| Quantity | 28 (14 REF S200635 and 14 S200636) |
| Distribution | Distribution was made to CA, CO, MD, MN, OH, TX, and WA. There was no foreign/military/government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120241 | LINEAR HIP STEM, SIZE 5 Encore Medical L.P., Feb 24, 2012 |