Recall Z-2658-2017 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Encore Medical, Lp
3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01, The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is intended to more closely match the kinematics of the knee, allowing some rotation
| Date | May 31, 2017 |
| Status | Terminated |
| Reason | Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert. |
| Root cause | Packaging process control |
| Action | The firm, DJO Global, sent an "URGENT FIELD SAFETY NOTICE" dated 5/31/2017 by email to its consignees on 5/31/2017. The notice described the product, problem and actions to be taken. The consignees were instructed to do the following actions by June 16, 2017: pass notice on to all those within the organization or to any organization where the affected product has been transferred; contact customer service at 1-800-456-8696 to place a replacement order and obtain shipment information; return all affected devices; and complete, sign and return the Acknowledgment and Receipt Form by email to: D |
| Quantity | 9 units |
| Distribution | Worldwide Distribution-US (nationwide) to states of: AL, TX, UT, and CA; and countries of: INDIA and GERMANY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091956 | HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712 Encore Medical L.P., Sep 28, 2010 |