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Terminated

Locking Cortical Screw 3.5mmX38mm REF 8161-35-038

FDA Recall Z-0716-2014 · Posted 2014-01-10

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeHRS
Date Initiated2013-12-19
Date Terminated2015-07-07
Product Quantity52

Reason for Recall

3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified that a 3.5mmx28mm Cortical Locking Screw is labeled as a 3.5mmx38mm Cortical Locking Screw.

Firm Action

URGENT MEDICAL DEVICE RECALL notices were sent to all consignees on December 19, 2013. Distributors who have affected hospitals in their regions were notified and provided with a copy of the notice that went to each hospital. Consignees are being contacted on an individual basis in an attempt to reconcile the product 100%. Fax back forms were provided to all consignees in order for Biomet to track returns. Non-responders will be contacted on an individual basis.

Root Cause

Labeling mix-ups

Distribution Pattern

US Distribution including states of: AZ, CA, GA, IL, KY, MI, NC, NH, NY, OH, PA, SD, TX, UT, and VA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082300ANATOMIC LOCKING PLATING SYSTEMDePuy Orthopaedics, Inc. · 2009-02-18K072832ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEMDePuy Orthopaedics, Inc. · 2007-12-14K072083SMALL FRAGMENT LOCKING PLATING SYSTEMDePuy Orthopaedics, Inc. · 2007-10-25

Official Source

View FDA Recall →

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

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