Recall Z-2242-2016 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Encore Medical, Lp
MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636
| Date | Jul 19, 2016 (initiated Jun 21, 2016) |
| Status | Terminated |
| Reason | Reported failure of the instrument. The retaining ring component of a neck trial became disassembled from the body of the neck. |
| Root cause | Process design |
| Action | The recalling firm notified affected consignees via letter on 6/21/16. The consignees were instructed to return the affected devices. |
| Quantity | 14 (7 sets) |
| Distribution | CO, ID, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974294 | ENCORE LINEAR POROUS COATED HIP Encore Orthopedics, Inc., Jan 12, 1998 |