FDA Medical Device Recalls (openFDA)
Michigan Orthopaedic Products, Inc.: 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 number
- Z-2351-2008
- 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.
- Status
- Terminated
- Initiated
- 2008-05-05
- Posted
- 2008-09-17
- Terminated
- 2008-10-21
- Reason
- 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
- 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
- 4 packages
- Distribution
- Class II Recall - Nationwide Distribution --- including the state of Michigan.
- Lot, serial or model codes
- Lots 259990 and 318630 (exp 07/2009).
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MQV
- Firm FEI
- 3006213866
- Firm city
- Grandville
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28