RecallRadar

FDA Device recall Z-0938-2013

Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072

On 2013-03-20 the FDA classified a Class II recall of Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072 by Synthes Usa Hq, citing lot number 7542279, of the 45 mm Click 'X Pedicle Screw (Part number 487.072), was incorrectly etched as "Click 'X Pedicle Screw 05.2 L40 TAN violet" although the actual length of….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0938-2013
ClassificationClass II
Statusterminated
Initiated2013-01-11
Published2013-03-20
Last updated2026-09-13 11:53 UTC
CompanySynthes Usa Hq
DistributionAL, CA, MO, MS, NJ, OR, TN

Product

Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072. Intended to provide precise and segmental stabilization of the spine in skeletally mature patients.

Reason

Lot number 7542279, of the 45 mm Click 'X Pedicle Screw (Part number 487.072), was incorrectly etched as "Click 'X Pedicle Screw 05.2 L40 TAN violet" although the actual length of the screw is 45 mm.

Identifiers

code_infoLot Number 7542279

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-0938-2013%22

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