Recall Z-0825-2008 ยท MQV Filler, Bone Void, Calcium Compound
EBI, L.P.
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
| Date | Feb 14, 2008 (initiated Oct 23, 2007) |
| Status | Terminated |
| Reason | 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) |
| Root cause | 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 | 19 units |
| Distribution | Nationwide to distributors/customers in NY, NC, MO, CA, FL and KS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.