CLASS II Device recall · Reported 4 Dec 2019 · FDA Enforcement Report
Cps Calcaneal Plate Sml recalled by Wright Medical Technology
Wright Medical Technology is recalling Cps Calcaneal Plate Sml. The recall was initiated on 8 Nov 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0573-2020
- FDA event ID
- 84180
- Recalling firm
- Wright Medical Technology, Arlington, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Nov 2016
- FDA classified
- 25 Nov 2019
- Reported
- 4 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 8 Nov 2016 | Recall initiated by company | |
| 25 Nov 2019 | Classified by FDA | +1112 days |
| 4 Dec 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm discovered a lack of adequate documentation confirming sterility on certain products.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
CPS CALCANEAL PLATE SML 54MM, Part Number DCS2805001
Where it was distributed
US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
Stores named: Walmart
Questions about this recall
Is Cps Calcaneal Plate Sml recalled?
Yes. Wright Medical Technology recalled Cps Calcaneal Plate Sml on 8 Nov 2016. The recall is Class II and its status is Terminated. Recall number Z-0573-2020.
Why was it recalled?
The firm discovered a lack of adequate documentation confirming sterility on certain products.
Which lots are affected?
Lot Number 1552873
Where was it sold?
US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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