Medtronic Grafton Matrix surgical strips: potential sterile barrier packaging defects
Medtronic is recalling Grafton Matrix Strips due to potential defects in the sterile packaging barrier. Non-conforming packaging could allow sterile barrier compromise in this surgical implant product.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 potential sterile barrier packaging defect in a surgical device with no reported illnesses or injuries. The hazard is theoretical rather than documented, as the source text does not report any adverse events related to these packaging non-conformances.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling multiple lots of Grafton Matrix Strips, demineralized bone matrix (DBM) surgical products available in multiple stock-keeping units with serial numbers ranging from A39563-061 through A46875-037. A total of 23,850 product units are included in this recall.
The recall addresses potential non-conformances in the dual-barrier, sterile pouch packaging system used for these products. Non-conforming packaging may result in a breach of the sterile barrier, which could compromise the sterility of the device.
The affected products have been distributed worldwide, including throughout the United States and to over 40 countries including Australia, Canada, Japan, United Kingdom, and others. No illnesses or injuries related to this packaging issue have been reported to date.
The recalled product
- Product
- Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; b) DBM S42280 8MMX1CMX20CM 2EA MATRX STRPS, REF S42280; c) DBM T42275 8MMX1CMX10CM 2 EACH GRAFTON M, REF T42275; d) DBM T42275AUS 8MMX1CMX10CM 2 EA GRFTON S, REF T42275AUS; e)…
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Affected units
- 23,850
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 S42275 8MMX1CMX10CM 2EA MATRIX STRPS
- REF S42275
- GTIN 00613994960931
- Serial Numbers: A42914
- A43126
- A43182
- A43185
- A43460
- A43613
- A43715
- A43896
- A44262
- A44388
- A44561
- A45997
- A46401
- A46690
- A46699
- A47001
- A47719
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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