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Recall Observatory FDA recall evidence

Device product

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.

Z-0390-2014

July 22, 2013

Class II

Product summary

Firm
Synthes USA HQ, Inc.
Event
Event 66666
Status
Terminated
Classification
Class II
Quantity
40248
Official record key
device-enforcement:Z-0390-2014

Official wording

Reason: 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.

Code information: All lots of parts 09.213.022S - 09.213.070S, and 09.223.032S- 09.223.090S.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.