DBX Demineralized Bone Matrix Putty fill volume mislabeled
DBX Demineralized Bone Matrix Putty units labeled as 10cc contain only 1cc of product, which may result in prolonged surgery. Affected units distributed in PA, TX, and WA.
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: This is an FDA Class II medical device recall with a known manufacturing defect affecting a surgical product. Although no illnesses or injuries have been reported, the fill volume discrepancy presents a risk of harm by potentially prolonging surgical procedures and increasing patient anesthesia exposure.
Plain-English summary
Musculoskeletal Transplant Foundation, Inc. is recalling DBX Demineralized Bone Matrix Putty (Model 038100) due to a fill volume discrepancy. The product is indicated for treatment of surgically created osseous defects or traumatic bone injuries.
The affected units are labeled as containing 10cc of product, but actually contain only 1cc of demineralized bone matrix putty. This discrepancy may result in prolongation of surgical procedures.
Approximately 18 units were distributed across Pennsylvania, Texas, and Washington. Healthcare providers and surgeons using this product should discontinue use and contact Musculoskeletal Transplant Foundation, Inc. for replacement or refund. Patients who have received this product should consult with their healthcare provider regarding their surgical outcome.
The recalled product
- Product
- DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. Model Number: 038100
- Manufacturer
- Musculoskeletal Transplant Foundation, Inc.
- Hazard
- fill-volume-mismatch
- labeling-error
- surgery-prolongation
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)
- 2025
Distribution
Distributed nationwide across the United States.
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