FDAClass IIDecember 7, 2016

Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm recall

Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile

Why was Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm recalled?

Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm diameter Drill Bit.

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?

Model/Catalog # 316.15 Lot/Serial Number U172728

Product
Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile
Recalling firm
Synthes (USA) Products LLC
Quantity
84 units
Distribution
Distributed Nationwide
Recall date
December 7, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls