Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0281-2018·Announced 2017-12-27

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.

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 2/5 (Moderate).

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…
Manufacturer: Zimmer Dental Inc
Category: Medical Device — Dental Implant Surgical Kit
Hazard: manufacturing-defect
functional-failure
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 →

Same manufacturer · Zimmer Dental Inc

See all →

Low
Zimmer Dental Implants Recalled for Incorrect Inner Package Labeling
FDA (Devices) · 2018-09-12
Moderate
Zimmer Dental Recalls Tapered Screw-Vent Implants Due to Labeling Error
FDA (Devices) · 2018-04-04
Moderate
Zimmer Dental Recalls Tapered Screw-Vent Implants Due to Mislabeled Lots
FDA (Devices) · 2018-04-04
High
Zimmer Dental GemLock Hex Driver Recalled for Manufacturing Defect
FDA (Devices) · 2017-12-27
High
Zimmer Dental Surgical Kits Recalled for Manufacturing Defect
FDA (Devices) · 2017-12-27

Same hazard · manufacturing defect