Z-2539-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 9, 2015
- Initiation Date
- August 14, 2015
- Termination Date
- February 26, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 110 units
Product Description
SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral Head diameter .46 mm, REF 9013.22.465; for use in shoulder implant surgery.
Reason for Recall
The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.
Distribution Pattern
US Distribution to the states of: OH, TX, NC, NY, CA, FL, KS, AL, MI, MT, CO, MO, NV, WA, MN and LA., and Internationally to Australia.
Code Information
Lot Numbers: 14AA234, 14AA235, 14AA233