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Terminated

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

FDA Recall Z-2210-2015 · Posted 2015-07-24

Recall StatusTerminated
Product CodeJDW
Date Initiated2015-05-27
Date Terminated2015-12-17
Product Quantity22 units

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.

Firm 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.

Root Cause

Labeling mix-ups

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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