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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Lot Codes / Batch Numbers
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
Products Sold
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
A medical device manufacturer is recalling OsteoStim Cervical Allograft (Lordotic Cervical Spacer) H. 7mm; W. 14mm; L. 10mm., Catalog Number: 4 due to Unapproved Testing: Tissue supplier (LifeLink) utilized unapproved diagnostic testing on certain lots of distributed donor tissue instead of the FDA a. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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)
Recommended Action
Per FDA guidance
Urgent Recall Notice letters were mailed on October 23, 2007, requesting location of all product including sub-accounts and return for credit.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026