Recall Z-2187-2012 ยท HRS Plate, Fixation, Bone
Zimmer, Inc.
The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-sterile Product is implantable screws indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones. These screws are intended for bicortical anchorage.
| Date | Aug 10, 2012 (initiated Jul 13, 2012) |
| Status | Terminated |
| Reason | Zimmer investigation following a complaint found one lot of NCB Polyaxial Locking Plate System NCB screws, 26mm, distributed in the United States contained incorrect 32 mm screws. |
| Root cause | Labeling mix-ups |
| Action | The firm, Zimmer, sent an "URGENT MEDICAL DEVICE RECALL" letter dated July 13, 2012, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to locate the implicated lot in their inventory and user accounts; return all packaged units of this lot; and provide Zimmer with the name, complete mailing address, and phone number of each user facility and surgeon that have used the product via E-mail to dawn.kindle@zimmer.com. Zimmer will send a follow-up Urgent Recall notification to these sub-accounts with instructions to verify the screw |
| Quantity | 24 to US Distributor with 7 further distributed |
| Distribution | Nationwide distribution: USA including states of: AZ, IL, IN, ME and NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042695 | NCB PLATING SYSTEM Zimmer GmbH, Oct 29, 2004 |