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Terminated

A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw

FDA Recall Z-2058-2015 · Posted 2015-07-10

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeHRS
Date Initiated2015-06-04
Date Terminated2016-03-22
Product Quantity50 units

Reason for Recall

Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection.

Firm Action

On 6/4/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors with instructions for removing the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday 8 a.m.to 5 p.m.

Root Cause

Packaging

Distribution Pattern

Domestic: None. International: Netherlands and Japan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111663TRAUMA INTERNAL FIXATION SYSTEMSDePuy Orthopaedics, Inc. · 2012-03-12

Official Source

View FDA Recall →

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

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