Zimmer Dental Guide Sleeves Recalled for Missing Supplemental Instructions
Zimmer Biomet is recalling specific dental guide sleeves because they were shipped with only standard instructions, missing required supplemental instructions.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to missing documentation (supplemental IFUs), which falls under the 'documentation issues' criterion for a Low severity score.
Plain-English summary
Zimmer Biomet is conducting a medical device field correction for various dental products, specifically Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, and Guide Sleeve REF 2223. The recall involves 349 products manufactured by Zimmer Dental Inc.
The reason for this field correction is that several parts were shipped to customers with only standard Instructions for Use (IFUs). All affected products were missing the required supplemental IFUs. The affected lots include # 63062148, 63386541, 0300481, 63386544, 63536617, 63426541, 3460410, 63426542, and 63503028.
The products were distributed in the US, Canada, France, Israel, Hong Kong, Netherlands, Japan, Italy, Belgium, Thailand, Saudi Arabia, Taiwan (Province of China), United Arab Emirates, Panama, Venezuela (Bolivarian Republic of), Chile, Colombia, Australia, Singapore, Costa Rica, Morocco, Trinidad and Tobago, Lebanon, Ecuador, Malaysia, Turkey, Serbia, Pakistan, and Korea (the Republic of). The source text does not specify specific actions for consumers or healthcare providers beyond the field correction.
The recalled product
- Product
- Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223
- Manufacturer
- Zimmer Dental Inc
- Category
- Medical Device — Dental
- Hazard
- Affected units
- 349
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 (9)
- lot # 63062148
- 63386541
- 0300481
- 63386544
- 63536617
- 63426541
- 3460410
- 63426542
- 63503028
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 7 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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