Device recall: AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)
Class II FDA enforcement event 93853. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.
Class II, in the words of FDA
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
Musculoskeletal Transplant Foundation, Inc. started this device recall on 22 Dec 2023. The firm address in the FDA record is in Edison, NJ. FDA put the recall in Class II. FDA event 93853 has 2 product records. The first FDA enforcement report date is 21 Feb 2024. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Product was distributed to Minnesota.
Recalling firm
Musculoskeletal Transplant Foundation, Inc., Edison, NJ.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1066-2024 | AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler) | 89 | Class II | Ongoing | 21 Feb 2024 |
| Z-1067-2024 | AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler) | 50 | Class II | Ongoing | 21 Feb 2024 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2023
- 917
- Share of these events in Class II
- 88%
- Product records in this event
- 2Median of the firm: 1
- Events of the firm on the register
- 8
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 22 Sep 2023 | DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defect | Device | Class II | 1 |
| 29 Mar 2021 | AFT Straight Tube (3/4 Filled) - Human Allograph Tissue for treatment of surgically-created osseous defects or osseous d | Device | Class II | 1 |
| 15 Aug 2019 | QuickGraft Model # 430PST | Device | Class II | 1 |
| 21 Apr 2016 | Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indicated for treatment of surgically-created oss | Device | Class II | 1 |
| 27 May 2015 | Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do Not freeze. | Device | Class II | 1 |
| 27 May 2015 | Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments are designed for the specific needs | Device | Class II | 1 |
| 4 Dec 2014 | DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone void filler. | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-1066-2024The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 93853. https://recallregister.com/fda/ii/93853/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Product was distributed to Minnesota.
- What quantity of product is in FDA event 93853?
- The event has 2 product records. The first record gives this quantity:
89
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2023 have the same class?
- 88% of the 917 device events that started in 2023 are in Class II.