Recall Z-1332-2023— Medtronic Sofamor Danek USA Inc
Class II · Ongoing
Class II FDA medical device recall by Medtronic Sofamor Danek USA Inc, initiated 2023-02-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203; b) ACCELERATE BG SET T50206 GRAFTON DBF 6CC, REF T50206; c) ACCELERATE BG SET T50209 GRAFTON DBF 9CC, REF T50209; d) ACCELERATE BG SET T50212 GRAFTON DBF12CC, REF T50212; Demineralized Bone Matrix (DBM) product. Reason: 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..
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-02-08
- Firm location
- Memphis, TN, United States
Product description
Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203; b) ACCELERATE BG SET T50206 GRAFTON DBF 6CC, REF T50206; c) ACCELERATE BG SET T50209 GRAFTON DBF 9CC, REF T50209; d) ACCELERATE BG SET T50212 GRAFTON DBF12CC, REF T50212; Demineralized Bone Matrix (DBM) product
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.