Bone void implants recalled over an incorrect product name on packaging
Berkeley Advanced Biomaterials is recalling 62 Tribio Implants 7.5mm x 40mm because the outer packaging carries an incorrect product name.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: packaging that names the wrong product can lead to the wrong implant being used, and no injuries are reported.
Plain-English summary
The Tribio Implant 7.5 mm x 40 mm, REF M80 SB008, from Berkeley Advanced Biomaterials, is being recalled. The implant is indicated for use in bony voids or gaps of the skeletal system, including the extremities, pelvis and posterolateral spine.
The recall follows an incorrect product label, with an incorrect product name identified on the outer packaging.
The recall covers 62 units carrying UDI 00816125023653, from lot EBL10B13C. The product was distributed in Tennessee. The FDA has classified the action as Class II.
A package that names the wrong product can lead to the wrong implant being selected in theatre. The enforcement record reports no injuries. Facilities holding the affected lot should quarantine it and follow the firm's instructions.
The recalled product
- Product
- Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created
- Manufacturer
- Berkeley Advanced Biomaterials, LLC
- Hazard
- mislabeled-packaging
- implant
- wrong-product
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- EBL10055-EBL10058 EBL10064 - EBL10073 EBL10075 - EBL10109
Distribution
Distributed nationwide across the United States.
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