AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)
Summary
The FDA issued a Class II for AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bon by Musculoskeletal Transplant Foundation, Inc.. Reason: Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudabilit.
Details
Source
Device Recall
External ID
Z-1067-2024
Action Date
2024-02-21
Status
Ongoing
Category
device
Product Description
AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)
Lot/Code Info: UDI-DI: W4184227005T0473 Donor Lots 00322029241137 and 00322039641144
Quantity Affected: 50
Reason for Recall
Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.
Distribution
Product was distributed to Minnesota.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-22
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Musculoskeletal Transplant Foundation, Inc. has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Musculoskeletal Transplant Foundation, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Musculoskeletal Transplant Foundation, Inc. have FDA actions?
Musculoskeletal Transplant Foundation, Inc. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1067-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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