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.
Recall
- Recall Number
- Z-2351-2008
- Event Number
- 48189
- Firm
- Michigan Orthopaedic Products, Inc.
- FEI Number
- 3006213866
- Product Code
- MQV
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- May 5, 2008
- Posted
- September 17, 2008
- Terminated
- October 21, 2008
- Address
- 2905 Wilson Ave Sw, Ste 100, Grandville, MI, 49418-1287
Description
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.
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).
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.
Class II Recall - Nationwide Distribution --- including the state of Michigan.
4 packages