Implant Direct Recalls Dental Implants Due to Packaging Error
Implant Direct is recalling 23 dental implants because a QA inspection found a healing collar was packaged instead of the implant.
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 packaging error where a different component was shipped. No injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity recall.
Plain-English summary
Implant Direct Sybron Manufacturing, LLC is recalling 23 units of the Implant Direct Legacy 2 Implant (REF: 833708). The recall was initiated after a quality assurance inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the ordered implant.
The affected products are identified by Lot #135128 with an expiration date of 3/12/20. The distribution pattern includes the United States (IN, VA, MD, TX, WA) and Japan. The agency has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected implants and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Category
- Medical Device — Dental Implants
- Affected units
- 23
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 #135128 Exp: 3/12/20
Distribution
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