Medtronic XPANSE Bone Insert Recalled for Sterile Packaging Non-Conformances
Medtronic is recalling XPANSE Bone Insert products due to packaging defects that may compromise the sterile barrier. Non-sterile packaging could allow contamination before surgical implantation.
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: FDA Class II recall of surgical implants with potential for sterility compromise and contamination risk without reported injury. This qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medtronic Sofamor Danek USA Inc. is recalling multiple XPANSE Bone Insert products due to potential non-conformances in the sterile pouch packaging system. Affected models include XPANSE SMALL-C 6, XPANSE MEDIUM-C 6, XPANSE MEDIUM-C 9, XPANSE LARGE-C 6, and XPANSE LARGE-C 9, with 4,348 units distributed worldwide.
The packaging non-conformances are related to the dual-barrier sterile pouch system designed to maintain product sterility. A breach in the sterile barrier could allow contamination of the bone graft material before surgical implantation.
These demineralized bone matrix (DBM) products are used as bone graft substitutes in orthopedic spinal fusion surgery. Affected units were distributed to hospitals and surgical facilities in the United States and numerous international locations. Healthcare providers should verify the serial numbers of their inventory against the recall list provided by Medtronic.
Patients who have received these implants should consult their healthcare provider if they have concerns about their implant or surgical procedure.
The recalled product
- Product
- Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106; b) DBM T600206 XPANSE MEDIUM-C 6, REF T600206; c) DBM T600209 XPANSE MEDIUM-C 9, REF T600209; d) DBM T600306 XPANSE LARGE-C 6, REF T600306; e) DBM T600309 XPANSE LARGE-C 9, REF T600309;
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Hazard
- packaging-defect
- sterility-breach
- contamination-risk
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 (20)
- a) DBM T600106 XPANSE SMALL-C 6
- REF T600106
- GTIN 00643169218314
- Serial Numbers: A41747-061
- A41747-062
- A41747-063
- A41747-064
- A41747-065
- A41747-066
- A41747-067
- A41747-068
- A41747-069
- A41747-070
- A41747-071
- A41747-072
- A41747-073
- A43745-061
- A43745-062
- A43745-063
- A43745-064
Distribution
Distributed nationwide across the United States.
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