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U.S. Department of Health and Human Services

Class 2 Device Recall AVS TL Trial Spacer

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  Class 2 Device Recall AVS TL Trial Spacer see related information
Date Initiated by Firm May 13, 2010
Date Posted July 08, 2010
Recall Status1 Terminated 3 on September 06, 2012
Recall Number Z-1966-2010
Recall Event ID 55710
Product Classification Orthopedic Manual Surgical Instrument - Product Code MDM
Product Stryker 16 MM AVS TL Trial Spacer; Catalog number: 48389416.
Manufactured by: Stryker Spine SAS, Cestas, France;
Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401.

Intended for use in the thoraco-lumbar spine.
Code Information Lot numbers: 064566 - 066356 - 067537 - 06D476 - 071453 - 072679 - 074605 - 075348 - 076577 - 07C642 - 07H725 - 082972.
Recalling Firm/
Manufacturer		 Stryker Spine
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information Contact Ms. Michelle Barry
201-760-8150
Manufacturer Reason
for Recall		 Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the trialling step of the AVS TL procedure.
FDA Determined
Cause 2		 Process control
Action Urgent Product Recall letters, dated May 13, 2010 were sent via Federal Express to all direct accounts (branches and hospitals) with a separate letter to surgeons. The letter identified the affected product and also described the issue, potential hazards, and risk mitigations. The letter also asked customers to quarantine any affected product and return to Stryker Spine. A Customer Response Form was provided and customers should contact their Stryker Spine Sales Rep for additional information on replacement product. Questions should be directed to Tiffani Rogers on 201-760-8206.
Quantity in Commerce 152 units
Distribution Nationwide Distribution.
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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