The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-sterile Product is implantable screws indicate

FDA device recall Z-2187-2012 · posted 2012-08-10 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

Reason for recall

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.

Action taken

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.

Root cause

Labeling mix-ups

Status

Terminated

Product code

HRS

Quantity affected

24 to US Distributor with 7 further distributed

Distribution

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

Date initiated

2012-07-13

Date posted

2012-08-10

Date terminated

2013-09-24

Location

Warsaw, IN

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