CLASS II Device recall · Reported 27 Jun 2018 · FDA Enforcement Report

Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set recalled

Synthes (USA) Products is recalling Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set, distributed in 12 states. The recall was initiated on 5 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesFL00860

Quantity recalled4

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-2246-2018
FDA event ID: 79754
Recalling firm: Synthes (USA) Products, West Chester, PA
Classification: Class II
Status: Terminated
Recall initiated: 5 Mar 2018
FDA classified: 15 Jun 2018
Reported: 27 Jun 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

5 Mar 2018	Recall initiated by company
15 Jun 2018	Classified by FDA	+102 days
27 Jun 2018	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

Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.

Product as listed by the FDA

Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set

Where it was distributed

Distributed to accounts in CA, IL, IN, KS, LA, MD, NC, NE, NJ, OR, TX, and VA. Foreign distribution to Canada.

California Illinois Indiana Kansas Louisiana Maryland North Carolina Nebraska New Jersey Oregon Texas Virginia

Questions about this recall

Why was it recalled?

Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.

Which lots are affected?

FL00860

Where was it sold?

Distributed to accounts in CA, IL, IN, KS, LA, MD, NC, NE, NJ, OR, TX, and VA. Foreign distribution to Canada.

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.

Other products in this recall event

2 other products · FDA event 79754

Reported	Class	Recall	Company	Reason	Where
27 Jun 2018	CLASS II	Part no. 690.380, Graphic Case F/7.3mm Cannulated Screw Set recalled	Synthes (USA) Products	Other	12 states
27 Jun 2018	CLASS II	Part no. 690.375, Graphic Case F/6.5mm & 7.3mm Combined Cannulated recalled	Synthes (USA) Products	Other	12 states

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