Z-2351-2008

InterGro DBM Demineralized Bone Matrix in a lipid carrier; Provided by: Lifelink Tissue Bank, Tampa, Florida...

Name: Z-2351-2008 InterGro DBM Demineralized Bone Matrix in a lipid carrier; Provided by: Lifelink Tissue Bank, Tampa, Florida...
Creator: Michigan Orthopaedic Products, Inc.
Published: 2008-05-05
License: https://open.fda.gov/license/

Michigan Orthopaedic Products, Inc. / initiated 2008-05-05 / Terminated / root cause: manufacturing process

FDA source

Michigan Orthopaedic Products, Inc. began a recall of InterGro DBM Demineralized Bone Matrix in a lipid carrier; Provided by: Lifelink Tissue Bank, Tampa, Florida, EBI A Biomet Company, Parsippany, New Jersey; REF... on 2008-05-05. The reason FDA records is "Exposure to temperature extremes -- Product was not stored under controlled conditions and may have been temperature abused. Exposure to temperature extremes could cause problems with device safety (e.g. risk of...". 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-2351-2008
Status: Terminated
Initiated: 2008-05-05
Posted: 2008-09-17
Terminated: 2008-10-21
Recalling firm: Michigan Orthopaedic Products, Inc.
Product: InterGro DBM Demineralized Bone Matrix in a lipid carrier; Provided by: Lifelink Tissue Bank, Tampa, Florida, EBI A Biomet Company, Parsippany, New Jersey; REF DBM002. InterGro DBM product contain human tissue (allograft bpm) and are intended for transplantation. Products are to be used for filling bony voids or gaps in the extremities, and pelvis that are not intrinsic to the bony stability of the structure.
Product code: MQV Filler, Bone Void, Calcium Compound
Reason for recall: Exposure to temperature extremes -- Product was not stored under controlled conditions and may have been temperature abused. Exposure to temperature extremes could cause problems with device safety (e.g. risk of infection) or problems with device effectiveness (e.g. lower healing rates if the factors or collagen in the device were affected by the temperature extremes).
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Three units were picked up from the consignee on or about 5/05/08. The implanting physician was verbally advised of the problem with the fourth unit. If you have any questions contact Michigan Orthopaedic Products, Inc. at (616) 249-8937.
Quantity in commerce: 4 packages
Distribution: Class II Recall - Nationwide Distribution --- including the state of Michigan.
Product codes and lots: Lots 259990 and 318630 (exp 07/2009).

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)