OsteoStim Cervical Allograft (Lordotic Cervical Spacer) H. 7mm; W. 14mm; L. 10mm., Catalog Number: 45-5537 and Catalog N
FDA device recall Z-0825-2008 · posted 2008-02-14 · Terminated
Recall details
- Recalling firm
- EBI, L.P.
- 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)
- Action taken
- Urgent Recall Notice letters were mailed on October 23, 2007, requesting location of all product including sub-accounts and return for credit.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MQV
- Quantity affected
- 19 units
- Distribution
- Nationwide to distributors/customers in NY, NC, MO, CA, FL and KS
- Date initiated
- 2007-10-23
- Date posted
- 2008-02-14
- Date terminated
- 2008-04-15
- Location
- Parsippany, NJ
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