Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005; c) DBM S45010 GRAFTON 10CC PASTE, REF S45010; d) DBM T45001 1CC PASTE GRAFTON PLUS, REF T45001; e) DBM T45001AUS 1CC PASTE GRAFTON PLUS, REF T45001AUS; f) DBM T45001INT 1CC PASTE GRAFTON PLUS, REF T45001INT; g) DBM T45005 5CC PASTE GRAFTON PLUS, REF T45005; h) DBM T45005INT 5CC PASTE GRAFTON PLUS, REF T45005INT; i) DBM T45010 10CC PASTE GRAFTON PLUS, REF T45010; j) DBM T45010AUS 10CC PASTE GRAFTON PLUS, REF T45010AUS; k) DBM T45010INT 10CC PASTE GRAFTON PLUS, REF T45010INT; Demineralized Bone Matrix (DBM) product
Class I - DangerousWhat Should You Do?
- Check if you have this product: a) DBM S45001 GRAFTON 1CC PASTE, REF S45001, GTIN 00613994961037, Serial Numbers: A46006, A40308, A42539, A43901, A44220, A45597, A45671, A46339, A48873, A51546, A52593, A52757, A53414; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005, GTIN 00613994961020, Serial Numbers: A40309, A43891, A45123, A45614, A46395, A46625, A46708, A48098, A48545, A48646, A48920, A49642, A50256, A51481, A51591, A52422, A52947, A53416, A53534, A53685, A53927, A54681; c) DBM S45010 GRAFTON 10CC PASTE, REF S45010, GTIN 00613994961013, Serial Numbers: A48673, A40169, A41945, A42622, A42931, A43105, A43124, A43340, A43904, A44606, A45676, A46344, A46456, A46730, A47917, A48147, A48149, A48275, A48980, A49864, A50243, A51016, A51041, A51755, A52183, A52329, A52709, A52713, A52954, A53755, A53944, A54258, A54365, A54784, A54804, A54988; d) DBM T45001 1CC PASTE GRAFTON PLUS, REF T45001, GTIN 00643169122949, Serial Numbers: A24679-156, A24679-157, A24679-158, A24679-159, A24679-160, 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- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medtronic Sofamor Danek USA Inc
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005; c) DBM S45010 GRAFTON 10CC PASTE, REF S45010; d) DBM T45001 1CC PASTE GRAFTON PLUS, REF T45001; e) DBM T45001AUS 1CC PASTE GRAFTON PLUS, REF T45001AUS; f) DBM T45001INT 1CC PASTE GRAFTON PLUS, REF T45001INT; g) DBM T45005 5CC PASTE GRAFTON PLUS, REF T45005; h) DBM T45005INT 5CC PASTE GRAFTON PLUS, REF T45005INT; i) DBM T45010 10CC PASTE GRAFTON PLUS, REF T45010; j) DBM T45010AUS 10CC PASTE GRAFTON PLUS, REF T45010AUS; k) DBM T45010INT 10CC PASTE GRAFTON PLUS, REF T45010INT; Demineralized Bone Matrix (DBM) product
Product Codes/Lot Numbers:
a) DBM S45001 GRAFTON 1CC PASTE, REF S45001, GTIN 00613994961037, Serial Numbers: A46006, A40308, A42539, A43901, A44220, A45597, A45671, A46339, A48873, A51546, A52593, A52757, A53414; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005, GTIN 00613994961020, Serial Numbers: A40309, A43891, A45123, A45614, A46395, A46625, A46708, A48098, A48545, A48646, A48920, A49642, A50256, A51481, A51591, A52422, A52947, A53416, A53534, A53685, A53927, A54681; c) DBM S45010 GRAFTON 10CC PASTE, REF S45010, GTIN 00613994961013, Serial Numbers: A48673, A40169, A41945, A42622, A42931, A43105, A43124, A43340, A43904, A44606, A45676, A46344, A46456, A46730, A47917, A48147, A48149, A48275, A48980, A49864, A50243, A51016, A51041, A51755, A52183, A52329, A52709, A52713, A52954, A53755, A53944, A54258, A54365, A54784, A54804, A54988; d) DBM T45001 1CC PASTE GRAFTON PLUS, REF T45001, GTIN 00643169122949, Serial Numbers: A24679-156, A24679-157, A24679-158, A24679-159, A24679-160, A24679-161, A24679-162, A24679-163, 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Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1329-2023
Related Recalls
Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.
Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix
Medtronic Sofamor Danek USA
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix
Medtronic Sofamor Danek USA
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.