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Terminated

Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; 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-2794-2015 · Posted 2015-09-18

Recalling FirmSynthes (USA) Products LLC
Recall StatusTerminated
Product CodeHWC
Date Initiated2015-08-11
Date Terminated2016-08-18
Product Quantity40038

Reason for Recall

DLS pin breakage during planned implant removal, after uneventful and successful healing of the fracture. This notice to additional consignees identified after recall Z-0390-2014, related to complaints of breakage located at the bottom of the screws and under the locking screw head.

Firm Action

Synthes sent an Urgent Notices of Medical Device Recall letter, dated August 11, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to return affected devices and response forms. For further questions please call (610) 719-6500.

Root Cause

Labeling False and Misleading

Distribution Pattern

Nationwide Distribution

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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