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Terminated

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.

FDA Recall Z-2351-2008 · Posted 2008-09-17

Recalling FirmMichigan Orthopaedic Products, Inc.
Recall StatusTerminated
Product CodeMQV
Date Initiated2008-05-05
Date Terminated2008-10-21
Product Quantity4 packages

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).

Firm 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.

Root Cause

Employee error

Distribution Pattern

Class II Recall - Nationwide Distribution --- including the state of Michigan.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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