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U.S. Department of Health and Human Services

Class 2 Device Recall Ray TFC Device with End Caps

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 Class 2 Recall
Ray TFC Device with End Caps
see related information
Date Posted October 20, 2008
Recall Status1 Terminated on November 04, 2008
Recall Number Z-0151-2009
Recall Event ID 49439
Premarket Approval
PMA Number
P950019
Product Classification Intervertebral Fusion Device With Bone Graft, Lumbar - Product Code MAX
Product Ray TFC Device with End Caps: Single Patient use; Sterile; Stryker Spine Ray Cage 7-2021 20 (catalog #) mm diameter x 21 mm long. Ray Cages are indicated for use with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels for L2 to S1.
Code Information Lot code 07A259
Recalling Firm/
Manufacturer
Stryker Spine
2 Pearl Ct
Allendale, New Jersey 07401-1611
For Additional Information Contact Susan Krasny, Ph.D., RAC
201-760-8150
Manufacturer Reason
for Recall
The label on one side on the Ray TFC Device (Ray Cage) is incorrect. It reads 20 mm x 26 mm instead of 20 mm x 21 mm.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action Urgent Product Recall notification letters were sent via Fed Express on August 18, 2008 to Stryker Branches and Hospital Risk Managers. The firm asked customers to examine their inventory and hospital locations to identify the product; reconcile all products on the Product Accountability Form and attached distribution sheet; and fax a copy of the Accountability Form and distribution sheet to Sarah Thompson within 5 days of receipt of the notice. All questions are to be directed to Susan Krasny at 201-760-8150.
Quantity in Commerce 69 units
Distribution Nationwide Distribution
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.
PMA Database PMAs with Product Code = MAX and Applicant = COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
PMAs with Product Code = MAX and Applicant = HOWMEDICA OSTEONICS CORP.
PMAs with Product Code = MAX and Applicant = STRYKER SPINE
PMAs with Product Code = MAX and Applicant = UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
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