Z-0825-2008

OsteoStim Cervical Allograft (Lordotic Cervical Spacer) H. 7mm; W. 14mm; L. 10mm., Catalog Number: 45-5537...

Name: Z-0825-2008 OsteoStim Cervical Allograft (Lordotic Cervical Spacer) H. 7mm; W. 14mm; L. 10mm., Catalog Number: 45-5537...
Creator: Ebi, L.p.
Published: 2007-10-23
License: https://open.fda.gov/license/

Ebi, LLC / initiated 2007-10-23 / Terminated / root cause: manufacturing process

FDA source

EBI, L.P. began a recall of OsteoStim Cervical Allograft (Lordotic Cervical Spacer) H. 7mm; W. 14mm; L. 10mm., Catalog Number: 45-5537 and Catalog Number : LGAL906, Distributed by EBI... on 2007-10-23. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0825-2008
Status: Terminated
Initiated: 2007-10-23
Posted: 2008-02-14
Terminated: 2008-04-15
Recalling firm: Ebi, LLC
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
Product code: MQV Filler, Bone Void, Calcium Compound
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)
Root cause tag: manufacturing process
FDA 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 in commerce: 19 units
Distribution: Nationwide to distributors/customers in NY, NC, MO, CA, FL and KS
Product codes and 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

Product code MQV

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)