—#110764

Product

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.

FDA product code: HRS — Plate, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K042695
Affected lot / code info: Part number 02.03155.026, lot 2649941

Why it was recalled

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 (FDA determination)

Labeling mix-ups

Action the firm took

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 length of any screws already in the implant rack inventory prior to use in surgery. All implicated product is to be returned. The customers were also instructed to complete and return the Inventory Return Certification form to Zimmer via fax at +1-574-372-4265. If you have any questions about this correction and/or product removal, contact Zimmer at +1-877-946-2761.

Recalling firm

Firm: Zimmer, Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: Nationwide distribution: USA including states of: AZ, IL, IN, ME and NJ.

Timeline

Recall initiated: 2012-07-13
Posted by FDA: 2012-08-10
Terminated: 2013-09-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #110764. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.