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Terminated

3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

FDA Recall Z-0390-2014 · Posted 2013-11-26

Recalling FirmSynthes USA HQ, Inc.
Recall StatusTerminated
Product CodeHWC
Date Initiated2013-07-22
Date Terminated2016-08-18
Product Quantity40248

Reason for Recall

All lots of 3.7mm and 5.0mm Dynamic Locking Screw (DLS) were recalled due to complaints of breakages at the distal tip of the pin identified after successful healing and during planned removal of the device.

Firm Action

Synthes sent an Urgent Notice: Medical Device Recall letter to Sales Reps and End Users on July 22, 2013. The letter identified the affect product, problem and actions to be taken. For questions call the Recall center at 610-719-5450.

Root Cause

Labeling False and Misleading

Distribution Pattern

Worldwide Distribution - USA (nationwide) and internationally to Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K1105923.7MM/5.0MM DYNAMIC LOCKING SCREWSynthes USA · 2011-07-25

Official Source

View FDA Recall →

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

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