Zimmer Dental Recalls Spline Twist Implants Due to Labeling Error
Zimmer Dental is recalling 1,044 Spline Twist Implants because the incorrect diameter size was printed on the inner vial.
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 and involves a minor labeling error (incorrect diameter size) with no reported injuries or illnesses, fitting the Moderate severity criteria.
Plain-English summary
Zimmer Dental Inc is recalling 1,044 units of Spline Twist Implants, Part No. 2135 (Lot No. 61792330). The recall is due to a labeling error where the incorrect diameter size was printed on the inner vial.
The affected implants are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses or as abutments for fixed or removable bridgework. The products were distributed nationwide in the United States and in Poland, Canada, Belgium, Italy, France, Israel, Morocco, Spain, Costa Rica, and Japan.
Consumers and healthcare providers should stop using the affected implants and contact Zimmer Dental Inc for further instructions.
The recalled product
- Product
- Spline Twist Implant, HA 3.25mmD X 15mmL; Part No. 2135. Zimmer Dental Spline implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary…
- Manufacturer
- Zimmer Dental Inc
- Category
- Medical Device — Dental Implant
- Hazard
- Affected units
- 1,044
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 No. 61792330
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
Same manufacturer · Zimmer Dental Inc
See all →- LowZimmer Dental Implants Recalled for Incorrect Inner Package Labeling
FDA (Devices) · 2018-09-12
- ModerateZimmer Dental Recalls Tapered Screw-Vent Implants Due to Labeling Error
FDA (Devices) · 2018-04-04
- ModerateZimmer Dental Recalls Tapered Screw-Vent Implants Due to Mislabeled Lots
FDA (Devices) · 2018-04-04
- ModerateZimmer Dental Tapered Screw-Vent MTX Implant Vial Caps Recalled for Cracking
FDA (Devices) · 2017-12-27
- HighZimmer Dental Surgical Kits Recalled for Manufacturing Defect
FDA (Devices) · 2017-12-27
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- LowZimmer Dental Implants Recalled for Incorrect Inner Package Labeling
FDA (Devices) · 2018-09-12
- ModerateZimmer Dental Implants Recalled for Missing Instructions
FDA (Devices) · 2016-02-17
- ModerateZimmer Dental Implants Recalled for Omitted Safety Information in Instructions
FDA (Devices) · 2016-02-17
- ModerateZimmer Recalls Tapered Screw-Vent Dental Implant Due to Labeling Error
FDA (Devices) · 2014-08-13
- ModerateZimmer Dental Implants Recalled for Missing Safety Information in Instructions
FDA (Devices) · 2016-02-17
- LowZimmer Dental Implants Recalled for Omitted Instructions
FDA (Devices) · 2016-02-17