Device recall: Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223
Class II FDA enforcement event 77911. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Zimmer Dental Inc started this device recall on 10 Jul 2017. The firm address in the FDA record is in Carlsbad, CA. FDA put the recall in Class II. FDA event 77911 has 7 product records. The first FDA enforcement report date is 4 Oct 2017. The record gives the status Terminated, with the termination date 5 Aug 2019.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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),…
Recalling firm
Zimmer Dental Inc, Carlsbad, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
7 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3204-2017 | Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223 | 349 products | Class II | Terminated | 4 Oct 2017 |
| Z-3205-2017 | THREAD RETRIEVAL DRILL REF 2224 | 237 products | Class II | Terminated | 4 Oct 2017 |
| Z-3206-2017 | ABUT GOLD FRICTION-FIT, REF HLA3G; ABUT GOLD FRICTION-FIT, REF HLA4G; COPING GOLD ENG 5.7 MM, REF HLA5G; COPING GOLD NON-ENG. 3.5, REF NEA3G; COPING GOLD NON-ENG. 4.5, REF NEA4G | 13,235 products | Class II | Terminated | 4 Oct 2017 |
| Z-3207-2017 | TRY-IN,ABUTMENT, CONT, 3.5X4.5, REF ZOAT34; TRY-IN, ABUTMENT, CONT, 4.5X5.5, REF ZOAT45; TRY-IN, ABUTMENT, CONT, 5.7X6.5, REF ZOAT56; TRY-IN KIT, ABUTMENT, CONT, REF ZOATKIT | 76 products | Class II | Terminated | 4 Oct 2017 |
| Z-3208-2017 | 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,… | 86 products | Class II | Terminated | 4 Oct 2017 |
| Z-3209-2017 | WAXING COPING, CONT 3.5 MM,ANG, REF ZOCWAX3A; WAXING COPING, CONT 3.5 MM, REF ZOCWAX3S; WAXING COPING, CONT 4.5MM, ANG, REF ZOCWAX4A; WAXING COPING, CONT 4.5MM, REF ZOCWAX4S; WAXING COPING, CONT, 5.5MM,ANG, REF ZOCWAX5A; WAXING COPING, CONT, 5.5MM, REF ZOCWAX5S; WAXING COPING, CONT, 6.5MM,ANG, REF ZOCWAX6A; WAXING… | 423 products | Class II | Terminated | 4 Oct 2017 |
| Z-3210-2017 | IMPLANT,1-PC,ANG,3.0X10MM, REF ZOP30A10; IMPLANT, 1-PC, ANG, 3.0X11.5MM, REF ZOP30A11; IMPLANT, 1 -PC,ANG,3.0X13MM, REF ZOP30A13; IMPLANT 1-PC STR 3.0X10, REF ZOP30S10; IMPLANT, 1-PC,STR,3.0X11.5MM, REF ZOP30S11; IMPLANT,1 -PC,STR,3.0X13MM, REF ZOP30S13 | 169 products | Class II | Terminated | 4 Oct 2017 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2017
- 1,091
- Share of these events in Class II
- 93%
- Product records in this event
- 7Median of the firm: 2
- Events of the firm on the register
- 10
Other events of the firm
Official channels
- FDA enforcement report Z-3204-2017The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 77911. https://recallregister.com/fda/ii/77911/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
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),…
- What quantity of product is in FDA event 77911?
- The event has 7 product records. The first record gives this quantity:
349 products
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2017 have the same class?
- 93% of the 1,091 device events that started in 2017 are in Class II.