The Recall Desk
HighFDA (Devices)·Z-1325-2023·Announced 2023-04-12

Medtronic Grafton Flex bone graft products recalled for packaging integrity defects

Medtronic is recalling Grafton Flex demineralized bone matrix products due to potential packaging non-conformances that could compromise sterile barrier integrity. Approximately 2,987 units were distributed worldwide.

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 sterile surgical device with potential packaging defects that could compromise sterile barrier integrity. No illnesses or injuries have been reported, making the hazard theoretical rather than actualized; per rubric criteria, theoretical hazards on risk-of-harm products are scored at most 3 (High).

Plain-English summary

Medtronic Sofamor Danek USA Inc is recalling Grafton Flex demineralized bone matrix (DBM) products due to potential non-conformances in the dual-barrier sterile pouch packaging system. The affected products are orthopedic and spinal surgery bone graft materials used in surgical procedures.

The company identified that the sterile pouch packaging may not conform to specifications, which could lead to a breach in the sterile barrier. A breached sterile barrier could allow contamination of the product before surgical use. No injuries or illnesses have been reported to date.

The recall affects approximately 2,987 units of multiple Grafton Flex product configurations (reference numbers S42090, T42090, T42090INT, T42100, T42100AUS, T42100INT, T42110, T42110AUS, T42110INT, and T42150INT) distributed worldwide including the United States, Australia, Canada, Japan, and more than 50 additional countries.

Healthcare providers and patients should not use affected units. If a unit has been implanted, contact Medtronic or a healthcare provider immediately. Medtronic is notifying distributors and hospitals to quarantine and return affected products.

The recalled product

Product
Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090; b) DBM T42090 1.5CMX1.5CM FLEX GRAFTON, REF T42090; c) DBM T42090INT 1.5CMX1.5CM FLEX GRAFTON, REF T42090INT; d) DBM T42100 2.5CMX10CM FLEX GRAFTON, REF T42100; e) DBM T42100AUS 2.5CMX10CM FLEX G
Manufacturer
Medtronic Sofamor Danek USA Inc
Category
Medical Device — Bone Graft / Orthopedic
Hazard
  • sterile-barrier-compromise
  • 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 S42090 GRAFTON 1.5CM X 1.5CM FLEX
  • REF S42090
  • GTIN 00613994961006
  • Serial Numbers: A50360
  • A52104
  • A55429
  • b) DBM T42090 1.5CMX1.5CM FLEX GRAFTON
  • REF T42090
  • GTIN 00643169122994
  • Serial Numbers: A40174-066
  • A40174-067
  • A40174-068
  • A40174-069
  • A40174-070
  • A40174-071
  • A40174-072
  • A40174-073
  • A40174-074
  • A40174-075
  • A40174-076

Distribution

Distributed nationwide across the United States.

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