Abutment Screw Retrieval Kit - Product Usage: The kit recall
Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as…
Why was Abutment Screw Retrieval Kit - Product Usage: The kit recalled?
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
(01)07332747083866(10)818727 (01)07332747083866(10)818683 Catalog# 37481
- Product
- Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as…
- Recalling firm
- Nobel Biocare Usa Llc
- Quantity
- 7 units
- Distribution
- Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE.
- Recall date
- February 26, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)