CLASS II Device recall · Reported 4 Oct 2017 · FDA Enforcement Report

Thread Retrieval Drill recalled by Zimmer Dental

Zimmer Dental is recalling Thread Retrieval Drill. The recall was initiated on 10 Jul 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codeslot # 63241114, 63321266, 63426543
Quantity recalled237 products

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-3205-2017
FDA event ID
77911
Recalling firm
Zimmer Dental, Carlsbad, CA
Classification
Class II
Status
Terminated
Recall initiated
10 Jul 2017
FDA classified
22 Sep 2017
Reported
4 Oct 2017
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

10 Jul 2017Recall initiated by company
22 Sep 2017Classified by FDA+74 days
4 Oct 2017Published 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

Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.

Product as listed by the FDA

THREAD RETRIEVAL DRILL REF 2224

Where it was distributed

US, Canada, France, Israel, Hong Kong, Netherlands, Japan, Italy, Belgium, Thailand, Saudi Arabia, Taiwan (Province of China), United Arab Emirates, Panama, Venezuela (Bolivarian Republic of), Chile, Colombia, Australia, Singapore, Costa Rica, Morocco, Trinidad and Tobago, Lebanon, Ecuador, Malaysia, Turkey, Serbia, Pakistan, Korea (the Republic of)

Questions about this recall

Is Thread Retrieval Drill recalled?

Yes. Zimmer Dental recalled Thread Retrieval Drill on 10 Jul 2017. The recall is Class II and its status is Terminated. Recall number Z-3205-2017.

Why was it recalled?

Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.

Which lots are affected?

lot # 63241114, 63321266, 63426543

Where was it sold?

US, Canada, France, Israel, Hong Kong, Netherlands, Japan, Italy, Belgium, Thailand, Saudi Arabia, Taiwan (Province of China), United Arab Emirates, Panama, Venezuela (Bolivarian Republic of), Chile, Colombia, Australia, Singapore, Costa Rica, Morocco, Trinidad and Tobago, Lebanon, Ecuador, Malaysia, Turkey, Serbia, Pakistan, Korea (the Republic of)

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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