CLASS II Device recall · Reported 1 Aug 2012 · FDA Enforcement Report

TI Multiloc Screw Length-Sterile recalled by Synthes USA HQ

Synthes USA HQ is recalling TI Multiloc Screw Length-Sterile, distributed nationwide in the US. The recall was initiated on 22 May 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #2721745 Expiration 4/29/2012 REF 04.019.028S

Quantity recalled20

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-2060-2012
FDA event ID: 62307
Recalling firm: Synthes USA HQ, West Chester, PA
Classification: Class II
Status: Terminated
Recall initiated: 22 May 2012
FDA classified: 23 Jul 2012
Reported: 1 Aug 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

22 May 2012	Recall initiated by company
23 Jul 2012	Classified by FDA	+62 days
1 Aug 2012	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

Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size.

Product as listed by the FDA

4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.019.028S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Multiloc Screw Length 28MM-Sterile Ref 04.019,038S. The Multiloc Screw 4.5 is used with a Multiloc PHN for treatment of proximal humerus fractures and is intended to be inserted through the Multiloc PHN until it engages the subchondral bone below the relative distal cortex (cortex closest to the humeral head, below the articular surface).

Where it was distributed

Nationwide Distribution-including the states of AZ, CA, FL, GA, IL, LA, MD, MN, NJ, NY, OH, PA, TN, TX, and VA.

Nationwide Arizona California Florida Georgia Illinois Louisiana Maryland Minnesota New Jersey New York Ohio Pennsylvania Tennessee Texas Virginia

Questions about this recall

Why was it recalled?

Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size.

Which lots are affected?

Lot #2721745 Expiration 4/29/2012 REF 04.019.028S

Where was it sold?

Nationwide Distribution-including the states of AZ, CA, FL, GA, IL, LA, MD, MN, NJ, NY, OH, PA, TN, TX, and VA.

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.

Other products in this recall event

1 other product · FDA event 62307

This product is part of a recall event; the main page for the event is TI Multiloc Screw Length-Sterile recalled by Synthes USA HQ.

Reported	Class	Recall	Company	Reason	Where
1 Aug 2012	CLASS II	TI Multiloc Screw Length-Sterile recalled by Synthes USA HQ	Synthes USA HQ	Labeling Errors	Nationwide

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
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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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