CLASS II Device recall · Reported 20 Mar 2013 · FDA Enforcement Report

Synthes Spine Titanium Click ' X Pedicle Screw Dual Core recalled

Synthes USA HQ is recalling Synthes Spine Titanium Click ' X Pedicle Screw Dual Core Thread Length, distributed in 7 states. The recall was initiated on 11 Jan 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number 7542279

Quantity recalled18

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0938-2013
FDA event ID: 64173
Recalling firm: Synthes USA HQ, West Chester, PA
Classification: Class II
Status: Terminated
Recall initiated: 11 Jan 2013
FDA classified: 11 Mar 2013
Reported: 20 Mar 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

11 Jan 2013	Recall initiated by company
11 Mar 2013	Classified by FDA	+59 days
20 Mar 2013	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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.

Where it was distributed

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

Alabama California Missouri Mississippi New Jersey Oregon Tennessee

Questions about this recall

Is Synthes Spine Titanium Click ' X Pedicle Screw Dual Core Thread Length recalled?

Yes. Synthes USA HQ recalled Synthes Spine Titanium Click ' X Pedicle Screw Dual Core Thread Length on 11 Jan 2013. The recall is Class II and its status is Terminated. Recall number Z-0938-2013.

Why was it recalled?

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.

Which lots are affected?

Lot Number 7542279

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Synthes USA HQ

All 56

Reported	Class	Recall	Company	Reason	Where
8 Jan 2014Device	CLASS II	Synthes Hand Switch - Electric Pen Drive recalled by Synthes USA HQ	Synthes USA HQ	Foreign Material	Nationwide
18 Dec 2013Device	CLASS II	Synthes TomoFix Plates The Synthes J5606-C TomoFix recalled	Synthes USA HQ	Other	Nationwide
18 Dec 2013Device	CLASS II	Synthes Trochanteric Fixation Nail As part of the Synthes recalled	Synthes USA HQ	Labeling Errors	Nationwide
11 Dec 2013Device	CLASS II	Synthes Soft Tissue Retractor Small Extendible recalled	Synthes USA HQ	Device Malfunction	Nationwide
11 Dec 2013Device	CLASS II	Titanium Trochanteric Fixation Nail recalled by Synthes USA HQ	Synthes USA HQ	Other	Nationwide

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2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide