FDAClass IINovember 28, 2012

Stryker Mantis Torque Wrench recall

Stryker MANTIS TORQUE WRENCH REF 48287028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.30…

Why was Stryker Mantis Torque Wrench recalled?

Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.

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?

Class I device, 510(K) exempt Catalog Number: 48287028 Lot Number: 098400

Product
Stryker MANTIS TORQUE WRENCH REF 48287028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.30…
Recalling firm
Stryker Spine
Quantity
19 units
Distribution
Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, France, Germany, Netherlands, Japan, Spain, Denmark, Switzerland, and the United Kingdom.
Recall date
November 28, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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