Date Initiated by Firm | May 13, 2010 |
Date Posted | July 08, 2010 |
Recall Status1 |
Terminated 3 on September 06, 2012 |
Recall Number | Z-1967-2010 |
Recall Event ID |
55710 |
Product Classification |
Orthopedic Manual Surgical Instrument - Product Code MDM
|
Product | Stryker 17 MM AVS TL Trial Spacer; Catalog number: 48389417
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: 066357 - 067540 - 06D477 - 071454 - 072680 - 074606 - 075349 - 076578 - 07C643 - 07H726 - 082973 - 084259. |
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 | 141 units |
Distribution | Nationwide Distribution. |
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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