RecallRadar

FDA Device recall Z-1062-2013

Flexible Grip which is part of the Synthes Universal Nail System

On 2013-04-17 the FDA classified a Class II recall of Flexible Grip which is part of the Synthes Universal Nail System by Synthes Usa Hq, citing synthes is initiating a voluntary recall of the Flexible Grip (Part number 355.28) which is part of the Universal Nail System, due to the potential lack of the ability to thorough….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1062-2013
ClassificationClass II
Statusterminated
Initiated2013-01-11
Published2013-04-17
Last updated2026-09-13 11:53 UTC
CompanySynthes Usa Hq
DistributionUS

Product

Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking) technique of treating stable diaphyseal fractures.

Reason

Synthes is initiating a voluntary recall of the Flexible Grip (Part number 355.28) which is part of the Universal Nail System, due to the potential lack of the ability to thoroughly clean the instrument.

Identifiers

code_infoPart number 355.28, all lot numbers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1062-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.