|
Class 3 Device Recall OsteoStim Cervical Allograft |
|
Date Initiated by Firm |
October 23, 2007 |
Date Posted |
February 14, 2008 |
Recall Status1 |
Terminated 3 on April 15, 2008 |
Recall Number |
Z-0825-2008 |
Recall Event ID |
45502 |
Product Classification |
Cervical Spacer - Product Code MQV
|
Product |
OsteoStim Cervical Allograft (Lordotic Cervical Spacer) H. 7mm; W. 14mm; L. 10mm., Catalog Number: 45-5537 and Catalog Number : LGAL906, Distributed by EBI. (dba Biomet Spine, Biomet Trauma, Biomet Bracing, Biomet Osteobiologics) Parsippany, New Jersey 07054 |
Code Information |
Catalog Number 45-5537;-Lot Numbers; 9677005006, 9677004606, 9677004906, 9677005206, 9677005306, 9677004406, 9677004506, 9677005506, 9677004706,, 9677005106, 9677004806, A0640037, A0630038, 9677005406, 9677005606, 967700416, and 9677004206; Catalog number LGAL906-Lot Number: 9346003406 |
Recalling Firm/ Manufacturer |
EBI, L.P. 100 Interpace Pkwy Parsippany NJ 07054-1149
|
For Additional Information Contact |
973-299-9300 Ext. 3904
|
Manufacturer Reason for Recall |
Unapproved Testing: Tissue supplier (LifeLink) utilized unapproved diagnostic testing on certain lots of distributed donor tissue instead of the FDA approved donor screening test. (Note: tissue samples were later re-tested by an approved method and found non-reactive)
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Urgent Recall Notice letters were mailed on October 23, 2007, requesting location of all product including sub-accounts and return for credit. |
Quantity in Commerce |
19 units |
Distribution |
Nationwide to distributors/customers in NY, NC, MO, CA, FL and KS |
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.
|
|
|
|