Zimmer Dental Thread Retrieval Drill Recall Due to Missing Supplemental Instructions
Zimmer Biomet is recalling Thread Retrieval Drills because they were shipped without supplemental instructions for use.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for missing documentation (supplemental IFUs) rather than a physical defect or contamination. Per the rubric, documentation issues are classified as Low severity.
Plain-English summary
Zimmer Biomet is conducting a medical device field correction for Thread Retrieval Drills (Ref 2224). The recall involves 237 units distributed across the United States, Canada, and 28 other countries.
The reason for the field correction is that the products were shipped to customers with only standard Instructions for Use (IFUs). The supplemental IFUs required for these specific products were missing from the shipment.
This recall affects dental professionals and facilities that received the affected lots. The source text does not provide specific instructions for consumers or end-users, as the products are professional medical devices. No injuries or illnesses have been reported in the source text.
The recalled product
- Product
- THREAD RETRIEVAL DRILL REF 2224
- Manufacturer
- Zimmer Dental Inc
- Hazard
- Affected units
- 237
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 (3)
- lot # 63241114
- 63321266
- 63426543
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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