FDAClass IINovember 12, 2014

Straumann Bone Level Implant 04.1 mm RC recall

Straumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021.4308 Product Usage: Dental implants are intended for…

Why was Straumann Bone Level Implant 04.1 mm RC recalled?

Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC)

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?

Lot number: GY256

Product
Straumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021.4308 Product Usage: Dental implants are intended for…
Recalling firm
Straumann USA, LLC
Quantity
111 units
Distribution
US Nationwide Distribution
Recall date
November 12, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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