Zimmer Dental Implant Surgical Kits Recalled for Manufacturing Defect
Zimmer Dental Inc. is recalling 166 surgical kits because a manufacturing defect may prevent the driver from properly engaging dental implants.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text describes a functional manufacturing defect but does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer Dental Inc. is recalling 166 units of the Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, starter (Ref STRKIT). The affected lots are 63688941, 63698713, 63710867, 63726919, 63732673, and 63759854. These kits were distributed nationwide in the United States and in numerous international markets, including Canada, Australia, and various countries in Europe, Asia, and the Middle East.
The recall was initiated because the device may contain a manufacturing condition affecting the geometry of the driver's hex feature. This defect may prevent the driver from properly engaging the fixture mount transfer and/or a dental implant. The kits are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments.
Healthcare professionals and consumers who possess these specific kits should stop using them and contact Zimmer Dental Inc. for further instructions on return or replacement. The recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, starter, Ref STRKIT. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the
- Manufacturer
- Zimmer Dental Inc
- Affected units
- 166
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 (6)
- Lot numbers 63688941
- 63698713
- 63710867
- 63726919
- 63732673
- and 63759854
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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.
See all 4 products in this recall →Related recalls
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