Demonstration only gel recalled because it may be placed in patients
Straumann USA is recalling 61 units of Emdogain because product intended for demonstration purposes only could be placed in patients.
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 3/5 (High).
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: Scored 3 under the risk-of-harm criterion: product not intended for patient use could be placed in a patient, and no injuries are reported.
Plain-English summary
Emdogain, article numbers 440.230V10 and 475.132V10, from Straumann USA, is being recalled.
The recall follows the possibility for this product, which is intended for demonstration purposes only, to be placed in patients.
The recall covers 61 units. Article 440.230V10 carries lots EPZM8, HPT6, KEWN9, NAAM6 and VAW80. The product was distributed in Arizona, California, Delaware, Florida, Idaho, Missouri, Tennessee, Texas, Utah and Virginia. The FDA has classified the action as Class II.
Demonstration product is not intended to go into a patient. The enforcement record reports no injuries. Practices holding affected stock should quarantine it and follow Straumann's instructions.
The recalled product
- Product
- Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
- Manufacturer
- Straumann USA LLC
- Category
- Medical Device — Dental biologic
- Affected units
- 61
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 (10)
- 1. Article Number: 440.230V10
- UDI-DI: N/A
- Lot Numbers: EPZM8
- HPT6
- KEWN9
- NAAM6
- VAW80
- 2. Article Number: 475.132V10
- Lot Numbers: CRL56
- HPHJ1
Distribution
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