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

Impression Cap Cont recalled by Zimmer Dental

Zimmer Dental is recalling Impression Cap Cont. 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 # 63275811, 63238369, 63286562, 63240994, 63250273, 63286560, 62556219, 62607124, 62675252, 62445681, 62086170, 62679151, 62734003

Quantity recalled86 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-3208-2017
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

IMPRESSION CAP CONT 3.5MM, REF ZOCIMP3A; MPRESSION CAP CONT 3.5MM, REF ZOCIMP3S; IMPRESSION CAP CONT 4.5MM ANG, REF ZOCIMP4A; IMPRESSION CAP CONT 4.5MM, REF ZOCIMP4S; IMPRESSION CAP,CONT,5.5MM, ANG, REF ZOCIMP5A; IMPRESSION CAP, CONT, 5.5MM, REF ZOCIMP5S; MPRESSION CAP, CONT, 6.5MM,ANG, REF ZOCIMP6A; IMPRESSION CAP, CONT, 6.5MM, REF ZOCIMP6S

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 Impression Cap Cont recalled?

Yes. Zimmer Dental recalled Impression Cap Cont on 10 Jul 2017. The recall is Class II and its status is Terminated. Recall number Z-3208-2017.

Why was it recalled?

Which lots are affected?

lot # 63275811, 63238369, 63286562, 63240994, 63250273, 63286560, 62556219, 62607124, 62675252, 62445681, 62086170, 62679151, 62734003

Where was it sold?

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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