Health product recall

Grafton and Grafton Plus Demineralized Bone Matrix

Last updated

Summary

Product
Grafton and Grafton Plus Demineralized Bone Matrix
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Grafton Plus Demineralized Bone Matrix (Dbm)

More than 10 numbers, contact manufacturer.

S45010
S45001
S45005

Grafton Demineralized Bone Matrix (Dbm)

More than 10 numbers, contact manufacturer.

S42090
S43101
S43102
S43105
S43103
S44115
S44150
S42200
S42210
S42275
S44135
S41120
S41150
S43110
S44125
S42280
S44105
S44145

Issue

Medtronic is voluntarily recalling specific serial numbers of Grafton™ DMB due to the potential for  breach in the sterile barrier. All lots manufactured before November 30 2022 are impacted.

Recall start date: February 15, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Orthopaedics
Companies

Medtronic Sofamor Danek Usa, Inc.

1800 Pyramid Place, Memphis, Tennessee, United States, 38132

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-73004

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