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Recall Observatory FDA recall evidence

Device product

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

Z-2210-2015

May 27, 2015

Class II

Product summary

Firm
Musculoskeletal Transplant Foundation, Inc.
Event
Event 71564
Status
Terminated
Classification
Class II
Quantity
22 units
Official record key
device-enforcement:Z-2210-2015

Official wording

Reason: 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.

Code information: Lot #06512078901017, Item #400920. The tissue is placed in a retainer and sealed in a blister pack

Distribution pattern: Distributed in the states of AZ, CO, MI, MN, NC, OH and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.