Zimmer Dental Recalls Implants Due to Missing Supplemental Instructions
Zimmer Biomet is recalling 169 dental implants because they were shipped without supplemental instructions for use.
What this means for you
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.
Plain-English summary
Zimmer Biomet is conducting a medical device field correction for various dental implant products manufactured by Zimmer Dental Inc. The recall involves 169 units of one-piece angled and straight dental implants in specific sizes (3.0x10mm, 3.0x11.5mm, and 3.0x13mm). The products were distributed to customers in the United States, Canada, and numerous international locations.
The reason for the field correction is that the products were shipped with only standard Instructions for Use (IFUs). All affected products were missing the required supplemental IFUs. This documentation issue means that customers may not have the complete instructions necessary for the proper use of the devices.
The recall covers specific lot numbers including 63234403, 62358420, and 62899483. Consumers and healthcare providers who possess these specific dental implants should contact Zimmer Biomet or their supplier to obtain the missing supplemental instructions and determine the appropriate next steps for the devices.
The recalled product
- Product
- 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
- Manufacturer
- Zimmer Dental Inc
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 169
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 (17)
- lot # 63234403
- 62358420
- 62899483
- 63542012
- 63220769
- 61378631
- 62899245
- 63409322
- 61268685
- 62358417
- 63091159
- 63110269
- 63522662
- 63529122
- 60807237
- 62367536
- 63471081
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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