Z-2210-2015Class II

Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do Not freeze

Name: Z-2210-2015 Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do Not freeze
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: labeling and UDI

FDA source

Musculoskeletal Transplant Foundation, Inc. began a recall of Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do Not freeze on 2015-05-27. FDA classified it as Class II and gives the reason as "Musculoskeletal Transplant Foundation (MTF) is recalling one lot of MTF's Allograft Cortical Pins because the lot was labeled as a 2.0 mm diameter pin and it may contain a 2.4 mm diameter pin". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2210-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-27
Posted: 2015-07-24
Terminated: 2015-12-17
Recalling firm: Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics
Product: Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do Not freeze.
Product code: JDW Pin, Fixation, Threaded
Reason for recall: Musculoskeletal Transplant Foundation (MTF) is recalling one lot of MTF's Allograft Cortical Pins because the lot was labeled as a 2.0 mm diameter pin and it may contain a 2.4 mm diameter pin.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Musculoskeletal Transplant Foundation initiated this recall by either telephoning their customers or by sending a recall letter dated 5/27/15 to the customer.
Quantity in commerce: 22 units
Distribution: Distributed in the states of AZ, CO, MI, MN, NC, OH and TX.
Product codes and lots: Lot #06512078901017, Item #400920. The tissue is placed in a retainer and sealed in a blister pack

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2210-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2210-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-05	2015-07-24

Product code JDW

K061498Class IIAllofix Anchor, 5.0 Mm AnchorMusculoskeletal Transplant Foundation / cleared 2006-07-06

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)