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U.S. Department of Health and Human Services

Class 2 Device Recall Radius Capsin

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  Class 2 Device Recall Radius Capsin see related information
Date Initiated by Firm February 19, 2008
Date Posted August 19, 2008
Recall Status1 Terminated 3 on August 19, 2008
Recall Number Z-1378-2008
Recall Event ID 46938
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Radius Capspin is a non-sterile instrument for use with other devices in spinal surgery.
Code Information 06A277, 06A279, 06D632 Catalog number: 486619210
Recalling Firm/
Manufacturer		 Stryker Spine
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information Contact Michelle Klein
201-760-8256
Manufacturer Reason
for Recall		 The Radius Capsin has separation of the tip from the inserter.
FDA Determined
Cause 2		 Device Design
Action Recall notification was sent via FedEx on February 19, 2008 to all branches/agencies. All questions are to be directed to Michelle Klein, Regulatory Compliance Specialist - 201-760-8256.
Quantity in Commerce 52
Distribution Product was distributed to a limited population during a product launch for the purposes of gathering feedback on the product.
Total Product Life Cycle TPLC Device Report
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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