Z-2075-2015Class II

Allofix Insertion Kit, 2.0 mm, Single Drill

Name: Z-2075-2015 Allofix Insertion Kit, 2.0 mm, Single Drill
Creator: Musculoskeletal Transplant Foundation, Inc.
Published: 2015-05-27
License: https://open.fda.gov/license/

Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics / initiated 2015-05-27 / Terminated / root cause: manufacturing process

FDA source

Musculoskeletal Transplant Foundation, Inc. began a recall of Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments are designed for the specific needs of the orthopedic surgeon and are... on 2015-05-27. FDA classified it as Class II and gives the reason as "Musculoskeletal Transplant Foundation is recalling a certain lot of Allofix Insertion Kits because they are labeled as having a 2.0mm diameter drill however it may contain a 2.4 mm diameter drill". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2075-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-27
Posted: 2015-07-15
Terminated: 2017-05-08
Recalling firm: Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics
Product: Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments are designed for the specific needs of the orthopedic surgeon and are intended to be used in conjunction with the associated allograft. This kit is for single use only.
Product code: HXY Brace, Drill
Reason for recall: Musculoskeletal Transplant Foundation is recalling a certain lot of Allofix Insertion Kits because they are labeled as having a 2.0mm diameter drill however it may contain a 2.4 mm diameter drill.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Musculoskeletal Transplant Foundation notified their affected customers of this recall by sending them a Voluntary Recall Notification Letter dated May 27, 2015 or via telephone. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Service at 1-800-433-6576.
Quantity in commerce: 117 units
Distribution: US Nationwide Distribution in the states of AZ, CA, CO, FL, IL, MI, MN, NC, NJ, NV, PA, TN, TX, UT, WA and WV.
Product codes and lots: Product Code: 900920, Serial #:906912041001, Expiry date 01Mar2017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2075-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2075-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-22	2015-07-15

Product code HXY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)