FDAClass IIDecember 4, 2019

CPS Calcaneal Plate SML 54mm recall: Sterility Concern

CPS CALCANEAL PLATE SML 54MM, Part Number DCS2805001

Why was CPS Calcaneal Plate SML 54mm recalled?

The firm discovered a lack of adequate documentation confirming sterility on certain products.

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?

Lot Number 1552873

Product
CPS CALCANEAL PLATE SML 54MM, Part Number DCS2805001
Recalling firm
Wright Medical Technology, Inc.
Quantity
42 units
Distribution
US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
Recall date
December 4, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls