FDAClass IIMay 24, 2017

Normed General Instruments 503004541: Werber recall

Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated for micro CBS…

Why was Normed General Instruments 503004541: Werber recalled?

the devices used a different raw material to produce two countersink products which has higher hardness and higher carbon content resulting in device damage.

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?

Lots: 13065 13569 13571

Product
Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated for micro CBS…
Recalling firm
Zimmer Gmbh
Quantity
138 (OUS 297)
Distribution
Single US consignee CO.
Recall date
May 24, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls