Medtronic Grafton Crunch sterile pouch packaging non-conformance recall
Medtronic is recalling Grafton Crunch demineralized bone matrix products due to potential packaging non-conformances that may compromise sterile barriers. 5,308 units are affected globally.
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 recall for a risk-of-harm sterile medical device with potential (not confirmed) packaging defects and no reported illnesses or injuries, meeting the rubric criterion for Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Sofamor Danek USA Inc. is recalling six models of Grafton Crunch, a demineralized bone matrix (DBM) product used in surgical applications. The recall involves 5,308 units with specific model numbers and serial number ranges documented by the FDA.
The recall is due to potential non-conformances in the dual-barrier, sterile pouch packaging system. These packaging defects may lead to a breach in the sterile barrier, which could compromise the product's sterility.
The affected products have been distributed worldwide, including throughout the United States and to numerous countries internationally. Healthcare facilities and surgical centers with these units in stock should consult with Medtronic Sofamor Danek USA Inc. regarding the specific serial numbers affected and appropriate next steps.
The recalled product
- Product
- Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b) DBM S44115 GRAFTON 15CC CRUNCH, REF S44115; c) DBM T44105 5CC GRAFTON CRUNCH, REF T44105; d) DBM T44105INT 5CC GRAFTON CRUNCH, REF T44105INT; e) DBM T44115 15CC GRAFTON CRUNCH, REF T44115; f) DB
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Hazard
- sterile-barrier-breach
- packaging-defect
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 S44105 GRAFTON 5CC CRUNCH
- REF S44105
- GTIN 00613994961099
- Serial Numbers: A41055
- A41991
- b) DBM S44115 GRAFTON 15CC CRUNCH
- REF S44115
- GTIN 00613994961082
- Serial Numbers: A46383
- A43751
- A43940
- A44572
- c) DBM T44105 5CC GRAFTON CRUNCH
- REF T44105
- GTIN 00643169123120
- Serial Numbers: A38507-041
- A38507-042
- A38507-043
- A38507-044
- A38507-045
Distribution
Distributed nationwide across the United States.
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