FDA Recall
Open, Classified
Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
Recall: Z-0843-2024
·
Initiated August 8, 2023
Recall
- Recall Number
- Z-0843-2024
- Event Number
- 93729
- Firm
- FX SHOULDER
- FEI Number
- 3014128390
- Product Code
- PHX
- Status
- Open, Classified
- Root Cause
- Labeling mix-ups
- Initiated
- August 8, 2023
- Posted
- January 29, 2024
- Address
- 13465 Midway Rd, Ste 310, Dallas, TX, 75244-5183
Description
Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
Reason
Centered glenosphere box may contain an eccentric glenosphere.
Action
On 8/8/23, the firm telephoned the customer and informed them of the recall. The customer was asked to quarantine the device, which was subsequently collected by the firm.
Distribution
US Nationwide distribution in the state of NJ.
Quantity
4