FDAClass IIJuly 13, 2016

Novation Press-Fit Splined RDD recall

Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. Product Usage Femoral stems are indicated for use in…

Why was Novation Press-Fit Splined RDD recalled?

Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another.

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?

Catalog #: 160-33-17; Serial#: 4192419, 4192420; Exp Date: 11/28/2020. Catalog #: 160-33-17; Serial#: 4223628, 4223629, 4223630, 4223631, 4223632, 4223633; Exp Date: 01/02/2021.

Product
Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. Product Usage Femoral stems are indicated for use in…
Recalling firm
Exactech, Inc.
Quantity
8 units
Distribution
Nationwide Distribuiton to OK, ME, NY, & Hawaii.
Recall date
July 13, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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