FDAClass IIAugust 24, 2016

Straumann Bone Level Implant recall

Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 021.4510

Why was Straumann Bone Level Implant recalled?

Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration

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 Numbers: LR810; LT122

Product
Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 021.4510
Recalling firm
Straumann Manufacturing, Inc.
Quantity
70 pieces
Distribution
Nationwide Distribution.
Recall date
August 24, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls