Zimmer Dental Surgical Kits Recalled for Manufacturing Defect
Zimmer Dental Inc. is recalling 30 surgical kits because a manufacturing defect may prevent the driver from properly engaging dental implants.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the defect presents a risk of harm (failure to engage implants) without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Dental Inc. is recalling 30 units of the Tapered SwissPlus & SwissPlus Implant Systems surgical kit (Ref OPCST). The affected products are identified by lot numbers 63666559 and 63705907. These kits are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments.
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 affected products were distributed worldwide, including the United States (nationwide), Canada, Australia, and numerous other countries. Consumers and healthcare providers should stop using the affected kits and contact Zimmer Dental Inc. for further instructions.
The recalled product
- Product
- Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref OPCST. 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 placement or removal
- Manufacturer
- Zimmer Dental Inc
- Affected units
- 30
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 (1)
- Lot numbers 63666559 and 63705907
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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