CLASS II Device recall · Reported 4 Dec 2013 · FDA Enforcement Report

Synthes Titanium Minimally Invasive Reduction Screw System recalled

Synthes USA HQ is recalling Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body, distributed nationwide in the US. The recall was initiated on 7 Sep 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots

Quantity recalled757

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-0395-2014
FDA event ID: 63230
Recalling firm: Synthes USA HQ, West Chester, PA
Classification: Class II
Status: Terminated
Recall initiated: 7 Sep 2012
FDA classified: 26 Nov 2013
Reported: 4 Dec 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

7 Sep 2012	Recall initiated by company
26 Nov 2013	Classified by FDA	+445 days
4 Dec 2013	Published in enforcement report	+8 days

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

Reason for recall

This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned during final tightening, the potential exists for locking caps to loosen post-operatively in certain situations.

Product as listed by the FDA

Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body, Part Number 04.631.500 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.

Where it was distributed

Nationwide Distribution including CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MT, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI.

Nationwide California Colorado Connecticut Florida Georgia Idaho Illinois Indiana Louisiana Massachusetts Maryland Michigan Minnesota Montana North Carolina New Jersey New York Ohio Oregon Pennsylvania

Questions about this recall

Is Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body recalled?

Yes. Synthes USA HQ recalled Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body on 7 Sep 2012. The recall is Class II and its status is Terminated. Recall number Z-0395-2014.

Why was it recalled?

Which lots are affected?

All lots

Where was it sold?

Nationwide Distribution including CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MT, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI.

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