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
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
- Device type
- Other Medical Devices
Timeline
| 10 Jul 2017 | Recall initiated by company | |
| 22 Sep 2017 | Classified by FDA | +74 days |
| 4 Oct 2017 | 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
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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