FDA Enforcement
Class II
Ongoing
13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. Part Number: 04.008.378S
Recall: Z-1234-2024
·
Reported March 13, 2024
Enforcement
- Recall Number
- Z-1234-2024
- Event ID
- 93924
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Synthes (USA) Products LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- March 13, 2024
- Initiation Date
- January 24, 2024
- Classification Date
- March 1, 2024
- Address
- 1301 Goshen Pkwy, West Chester, PA, 19380-5986, United States
Description
13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. Part Number: 04.008.378S
Reason
Products not sterilized, sterility cannot be confirmed
Code Info
UDI: 10886982087331 Lot Number: 41P2222
Distribution
Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa.
Quantity
5 units