FDAClass IIJanuary 23, 2019

Maximum Variable Pitch Compression Screw Caddy recall

Maximum Variable Pitch Compression Screw Caddy, Reference Number 231201003 Product Usage: Intended to carry implants and instruments during regular…

Why was Maximum Variable Pitch Compression Screw Caddy recalled?

There is a potential for silicone shedding during cleaning and sterilization.

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 453392 453918 453919 469917 475577 481064 481065 486820 498695 506818 512867 512868

Product
Maximum Variable Pitch Compression Screw Caddy, Reference Number 231201003 Product Usage: Intended to carry implants and instruments during regular…
Recalling firm
Zimmer Biomet, Inc.
Quantity
971 in total
Distribution
Worldwide Distribution - US Nationwide, The products were distributed to the following foreign countries: Australia, Chile, Netherlands.
Recall date
January 23, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls