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U.S. Department of Health and Human Services

Class 2 Device Recall 6.5 Cancellous Bone Screw 25 mm

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 Class 2 Recall
6.5 Cancellous Bone Screw 25 mm
see related information
Date Posted September 22, 2008
Recall Status1 Terminated on September 23, 2008
Recall Number Z-2007-2008
Recall Event ID 48131
Premarket Notification
510(K) Numbers
K873251  K894124 
Product Classification Screw, Fixation, Bone - Product Code HWC
Product 6.5 Cancellous Bone Screw 25 mm; Responsible Firm on Label: Manufacturer, Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA, A Subsidiary of Stryker Corp., Made in USA; Catalog Number: 2030-6525-1 The Omnifit bone screws are intended to augment the fixation of compatible acetabular cups.
Code Information Lot Code: 35323605
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 07430-2002
For Additional Information Contact Lawrence Ross
201-831-5972
Manufacturer Reason
for Recall
The firm has been made aware that one lot of 6.5 Cancellous Bone Screws 25mm was packaged and labeled as 25 mm in length when it maybe 20 mm in length.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action The recalling firm sent notification letters and Product Accountability Forms via Fed Ex with return receipt on December 20, 2005. The notification letter described the problem, and asked customers to inventory and quarantine the affected product. Customers were told to return the affected product to Stryker. Contact Stryker at 1-201-831-5825 for assistance.
Quantity in Commerce 29 units
Distribution nationwide
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = OSTEONICS CORP.
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