Recall Z-1130-2014 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Djo Surgical
FMP X-alt Acetabular Liner This acetabular liner is intended for use with DJO Surgical hip systems. It is used with an acetabular shell to replicate the kinematics of a natural hip.
| Date | Mar 4, 2014 (initiated Feb 7, 2014) |
| Status | Terminated |
| Reason | Packaging error -- two different types and sizes of acetabular liners used during hip replacement surgery were mistakenly packaged into each other's outer boxes after sterilization, resulting in the products being mislabeled. The units labeled as Model/Catalog Number 931-28-248 Lot/Serial Number 685F1034 on the outside and containing Model/Catalog Number 932-36-252, Lot# 728F1089 on the inside (1 |
| Root cause | Packaging process control |
| Action | DJO Global sent an Urgent Field Safety Notice dated February 7, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. All 10 devices with the outer label of 931-28-248, Lot#685F1034 were found in-house and were quarantined. The agencies who have the affected product (devices labeled as 932-36-252, Lot# 728F1089 containing 931-28-248, Lot#685F1034) were contacted to quarantine their devices. Of the affected devices, 2 of the lot of 10 have already been returned via product complaint. Customers were instructed to pass on th |
| Quantity | 10 units of Model/Catalog Number 931-28-248 Lot/Serial Number(s) 685F1034 labeled asModel/Catalog Number 932-36-252, Lot |
| Distribution | Nationwide Distribution - USA including TX, LA, FL, CA, and AZ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072154 | FOUNDATION (FMP) POROUS COATED SPIKED ACETABULAR SYSTEM Encore Medical L.P., Dec 14, 2007 |