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

2.4 and Locking Screw Slf-tpng recalled by Synthes USA HQ

Synthes USA HQ is recalling 2.4 and Locking Screw Slf-tpng with T8 Stardrive Recess Fixation of fractures, distributed nationwide in the US. The recall was initiated on 31 Jul 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 3420620

Quantity recalled98

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-0380-2014
FDA event ID: 66411
Recalling firm: Synthes USA HQ, West Chester, PA
Classification: Class II
Status: Terminated
Recall initiated: 31 Jul 2013
FDA classified: 22 Nov 2013
Reported: 4 Dec 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

31 Jul 2013	Recall initiated by company
22 Nov 2013	Classified by FDA	+114 days
4 Dec 2013	Published in enforcement report	+12 days

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

Reason for recall

Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issue. The SS 2.7mm Screw was labeled as SS 2.4 mm Screw.

Product as listed by the FDA

2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.

Where it was distributed

Nationwide Distribution including PA, CA, FL, MO, KS, IN, IL, WV, KY, LA, NM, SC, IA, TX, AZ, GA, NC, OK, NY, TN, MI, CO, and MT.

Nationwide Arizona California Colorado Florida Georgia Iowa Illinois Indiana Kansas Kentucky Louisiana Michigan Missouri Montana North Carolina New Mexico New York Oklahoma Pennsylvania South Carolina

Questions about this recall

Why was it recalled?

Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issue. The SS 2.7mm Screw was labeled as SS 2.4 mm Screw.

Which lots are affected?

Lot 3420620

Where was it sold?

Nationwide Distribution including PA, CA, FL, MO, KS, IN, IL, WV, KY, LA, NM, SC, IA, TX, AZ, GA, NC, OK, NY, TN, MI, CO, and MT.

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 26 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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