CLASS II Device recall · Reported 18 Jan 2017 · FDA Enforcement Report

GoDirect Screw-Retaining Top Part Numbers recalled

Implant Direct Sybron Manufacturing is recalling GoDirect Screw-Retaining Top Part Numbers: 4500-61, distributed in Washington. The recall was initiated on 28 Nov 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #75808

Quantity recalled14

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-0961-2017
FDA event ID: 75838
Recalling firm: Implant Direct Sybron Manufacturing, Westlake Village, CA
Classification: Class II
Status: Terminated
Recall initiated: 28 Nov 2016
FDA classified: 9 Jan 2017
Reported: 18 Jan 2017
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

28 Nov 2016	Recall initiated by company
9 Jan 2017	Classified by FDA	+42 days
18 Jan 2017	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

Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top.

Product as listed by the FDA

GoDirect Screw-Retaining Top Part Numbers: 4500-61

Where it was distributed

U.S. distribution to the following; WA. Foreign distribution to the following; Netherlands.

Washington

Questions about this recall

Why was it recalled?

Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top.

Which lots are affected?

Lot #75808

Where was it sold?

U.S. distribution to the following; WA. Foreign distribution to the following; Netherlands.

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 Implant Direct Sybron Manufacturing

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10 Nov 2021Device	CLASS II	ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD recalled	Implant Direct Sybron Manufacturing	Packaging Defects	Nationwide
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