Recall Z-0825-2008
Ebi, L.P. · initiated October 23, 2007
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
Codes / lots: 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
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: Nonconforming Material/Component
Action taken
Urgent Recall Notice letters were mailed on October 23, 2007, requesting location of all product including sub-accounts and return for credit.
Details
- Recall number
- Z-0825-2008
- Initiated
- October 23, 2007
- Posted by FDA
- February 14, 2008
- Terminated
- April 15, 2008
- Product code
- MQV – Filler, Bone Void, Calcium Compound
- Quantity
- 19 units
- Distribution
- Nationwide to distributors/customers in NY, NC, MO, CA, FL and KS
- Recalling firm
- Ebi, L.P., Parsippany, NJ