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B-GENIN Strip

BERKELEY ADVANCED BIOMATERIALS, LLC · Model BG5-100X5-12 · UDI-DI 00816125026166

MBP MQV Prescription

510(k) clearances

185

Adverse events (1 deaths)

Recalls

Facilities

Description

B-GENIN is a bone void filler consisting of purified bovine collagen and demineralized bone matrix (DBM). The collagen component is biocompatible. After it is implanted, it resorbs and is later replaced by natural bone. B-GENIN is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. The bone graft can be mixed blood prior to use at the physician's discretion.

Recalls

Date	Firm	Reason
2023-09-26	Medtronic Sofamor Danek USA Inc	Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requiremen
2023-09-26	Medtronic Sofamor Danek USA Inc	Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requiremen
2023-09-26	Medtronic Sofamor Danek USA Inc	Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requiremen
2023-09-26	Medtronic Sofamor Danek USA Inc	Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requiremen
2023-09-26	Medtronic Sofamor Danek USA Inc	Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requiremen
2023-09-26	Medtronic Sofamor Danek USA Inc	Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requiremen
2023-09-26	Medtronic Sofamor Danek USA Inc	Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requiremen
2023-02-08	Medtronic Sofamor Danek USA Inc	Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
2023-02-08	Medtronic Sofamor Danek USA Inc	Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
2023-02-08	Medtronic Sofamor Danek USA Inc	Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.