Zimmer Dental GemLock Hex Driver Recalled for Manufacturing Defect
Zimmer Dental Inc. is recalling 356 GemLock RHD2.5 Hex Drivers because a manufacturing defect may prevent the tool from properly engaging dental fixtures.
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 involves a risk-of-harm product (medical device) where the defect prevents proper engagement, but the source text does not report any injuries or illnesses.
Plain-English summary
Zimmer Dental Inc. is recalling 356 units of the GemLock RHD2.5 Hex Driver. These devices are manually powered accessories used to aid in the placement or removal of endosseous dental implants and abutments. The recall covers specific lot numbers: 63563072, 63572755, 63583270, and 63755802.
The recall is being issued because the devices 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 units were distributed worldwide, including in the United States, Canada, Australia, and numerous other countries.
Consumers and healthcare professionals should stop using the affected devices immediately. They should contact Zimmer Dental Inc. for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Zimmer Dental GemLock RHD2.5 Hex Driver. 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 of endosseous dental implants and abutment
- Manufacturer
- Zimmer Dental Inc
- Affected units
- 356
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 (4)
- Lot numbers 63563072
- 63572755
- 63583270
- and 63755802
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.
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