FDAClass IIMarch 5, 2014

Specialty Straight Static Inserter Assembly Product recall

Specialty Straight Static Inserter Assembly Product Usage: This instrument is a part of the Navigator product brand . It is used for implant insertion…

Why was Specialty Straight Static Inserter Assembly Product recalled?

Stryker has received complaints from customers relating to fracture along the weld that binds the handle to the shaft of the static inserter.

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?

D109140 Catalog # IS3009AVS Lot Serial # 3664, 3759, 3843, 3913, 4079, 4195 and 4242

Product
Specialty Straight Static Inserter Assembly Product Usage: This instrument is a part of the Navigator product brand . It is used for implant insertion…
Recalling firm
Stryker Spine
Quantity
21 units
Distribution
US Nationwide Distribution
Recall date
March 5, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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