FDA Enforcement
Class II
Terminated
SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.
Recall: Z-0585-2016
·
Reported January 13, 2016
Enforcement
- Recall Number
- Z-0585-2016
- Event ID
- 72774
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Synthes (USA) Products LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 13, 2016
- Initiation Date
- December 1, 2015
- Classification Date
- January 4, 2016
- Termination Date
- August 26, 2016
- Address
- 1301 Goshen Pkwy, N/A, West Chester, PA, 19380-5986, United States
Description
SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.
Reason
The 13.5mm Medullary Reamer head, lot #F-17180, is etched as dimension 13.5mm while the actual dimension is 14mm.
Code Info
Part number: 352.135; Lot number: F-17180
Distribution
US nationwide distibution.
Quantity
65