CLASS II Device recall · Reported 14 Nov 2012 · FDA Enforcement Report

Dynesys¿ Set screw M6 recalled by Zimmer

Zimmer is recalling Dynesys¿ Set screw M6, distributed nationwide in the US. The recall was initiated on 4 Sep 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesREF Numbers: 01.03710.006 and 01.03711.006 Lot 2381797, 2429082

Quantity recalled58

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-0236-2013
FDA event ID: 63103
Recalling firm: Zimmer, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 4 Sep 2012
FDA classified: 6 Nov 2012
Reported: 14 Nov 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

4 Sep 2012	Recall initiated by company
6 Nov 2012	Classified by FDA	+63 days
14 Nov 2012	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

Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info

Product as listed by the FDA

Dynesys¿ Set screw M6

Where it was distributed

Nationwide Distribution.

Nationwide

Questions about this recall

Is Dynesys¿ Set screw M6 recalled?

Yes. Zimmer recalled Dynesys¿ Set screw M6 on 4 Sep 2012. The recall is Class II and its status is Terminated. Recall number Z-0236-2013.

Why was it recalled?

Which lots are affected?

REF Numbers: 01.03710.006 and 01.03711.006 Lot 2381797, 2429082

Where was it sold?

Nationwide Distribution.

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.

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