Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-0938-2013

January 11, 2013

Class II

Product summary

Firm
Synthes USA HQ, Inc.
Event
Event 64173
Status
Terminated
Classification
Class II
Quantity
18
Official record key
device-enforcement:Z-0938-2013

Official wording

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.

Code information: Lot Number 7542279

Distribution pattern: Distributed in the states of AL, CA, MS, MO, NJ, OR, and TN.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.