Medtronic Grafton Putty Bone Matrix Packaging Sterile Barrier Non-Conformance
Medtronic recalls 186,889 units of Grafton Putty demineralized bone matrix product due to potential packaging defects that could compromise sterile barrier integrity. No illnesses reported.
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 with theoretical risk of sterile barrier breach in a medical device product. The source explicitly describes 'potential for' and 'may lead to' breach, indicating no reported illnesses or injuries. Per the rubric, risk-of-harm products without reported harm score 3 (High) maximum.
Plain-English summary
Medtronic Sofamor Danek USA Inc. is recalling 186,889 units of Grafton Putty demineralized bone matrix (DBM) product. Multiple product sizes (0.5CC to 10CC) are affected across numerous lot serial numbers.
The recall is due to potential non-conformances in the dual-barrier, sterile pouch packaging system. Non-conforming packaging could breach the sterile barrier, potentially compromising the product's sterility.
The affected products have been distributed worldwide, including throughout the United States and over 40 additional countries. Healthcare facilities should verify their inventory against the affected serial numbers provided by the FDA.
No illnesses or injuries related to this packaging defect have been reported. Affected healthcare providers should contact Medtronic for instructions on product disposition and replacement options.
The recalled product
- Product
- Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102; c) DBM S43103 GRAFTON 2.5CC PUTTY, REF S43103; d) DBM S43105 GRAFTON 5CC PUTTY, REF S43105; e) DBM S43110 GRAFTON 10CC PUTTY, REF S43110; f) DBM
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Affected units
- 186,889
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 S43101 GRAFTON 0.5CC PUTTY
- REF S43101
- GTIN 00613994960900
- Serial Numbers: A43107
- A44312
- A44898
- A45026
- A47094
- A48070
- A48239
- A48726
- A54374
- b) DBM S43102 GRAFTON 1CC PUTTY
- REF S43102
- GTIN 00613994960894
- Serial Numbers: A39801
- A40711
- A42973
- A43546
- A44572
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Medtronic Sofamor Danek USA Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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