Date Initiated by Firm | July 13, 2012 |
Date Posted | August 10, 2012 |
Recall Status1 |
Terminated 3 on September 24, 2013 |
Recall Number | Z-2187-2012 |
Recall Event ID |
62499 |
510(K)Number | K042695 |
Product Classification |
Plate, fixation, bone - Product Code HRS
|
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. |
Code Information |
Part number 02.03155.026, lot 2649941 |
Recalling Firm/ Manufacturer |
Zimmer, Inc. 345 E Main St Warsaw IN 46580-2746
|
For Additional Information Contact | 574-372-4807 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 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. |
Quantity in Commerce | 24 to US Distributor with 7 further distributed |
Distribution | Nationwide distribution: USA including states of: AZ, IL, IN, ME and NJ. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = HRS
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