FDAClass IIApril 26, 2017

Tapered SwissPlus Implant System recall

Tapered SwissPlus Implant System, Model No. SPB10

Why was Tapered SwissPlus Implant System recalled?

It was manufactured with the minor diameter of the internal thread that is below specification.

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 #63498673; UDI: (01) 008890240177 (10) 63498673 (17) 200731

Product
Tapered SwissPlus Implant System, Model No. SPB10
Recalling firm
Zimmer Dental Inc
Quantity
188 units
Distribution
Worldwide: ZA, FR, IT, IR
Recall date
April 26, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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