Zimmer Dental Recalls Impression Caps Due to Missing Supplemental Instructions
Zimmer Biomet is conducting a field correction for dental impression caps because they were shipped without supplemental instructions for use.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to missing documentation (supplemental IFUs) rather than a physical defect or contamination, which aligns with the rubric for documentation issues and packaging-only problems.
Plain-English summary
Zimmer Biomet is conducting a medical device field correction for various dental impression caps manufactured by Zimmer Dental Inc. The affected products include impression caps in 3.5mm, 4.5mm, 5.5mm, and 6.5mm sizes, both standard and angled, with reference numbers ranging from ZOCIMP3A to ZOCIMP6S.
The recall is being conducted because the products were shipped to customers with only standard Instructions for Use (IFUs), missing the required supplemental IFUs. This documentation issue affects 86 products across specific lot numbers, including 63275811, 63238369, and 63286562.
The affected units were distributed in the United States, Canada, France, Israel, and numerous other international markets. Users of these dental products should verify their documentation and contact the manufacturer for the missing supplemental instructions.
The recalled product
- Product
- 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…
- Manufacturer
- Zimmer Dental Inc
- Hazard
- Affected units
- 86
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- lot # 63275811
- 63238369
- 63286562
- 63240994
- 63250273
- 63286560
- 62556219
- 62607124
- 62675252
- 62445681
- 62086170
- 62679151
- 62734003
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 7 recalled by Zimmer Dental Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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