FDA Enforcement
Class II
Terminated
CPS CALCANEAL PLATE SML 54MM, Part Number DCS2805001
Recall: Z-0573-2020
·
Reported December 4, 2019
Enforcement
- Recall Number
- Z-0573-2020
- Event ID
- 84180
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Wright Medical Technology, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 4, 2019
- Initiation Date
- November 8, 2016
- Classification Date
- November 25, 2019
- Termination Date
- November 3, 2020
- Address
- 11576 Memphis Arlington Rd, Arlington, TN, 38002-9497, United States
Description
CPS CALCANEAL PLATE SML 54MM, Part Number DCS2805001
Reason
The firm discovered a lack of adequate documentation confirming sterility on certain products.
Code Info
Lot Number 1552873
Distribution
US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
Quantity
42 units