Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
FX SHOULDER · Centered glenosphere box may contain an eccentric glenosphere.
Open FDA's page for this record- Cfres ID
- 205322
- Product res number
- Z-0843-2024
- Event date initiated
- 2023-08-08
- Event date posted
- 2024-01-29
- Recall status
- Open, Classified
- Res event number
- 93729
- Product code
- PHX
- Product description
- Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
- Code info
- UDI-DI: 03701037309551, Lot: U0191
- Firm FEI number
- 3014128390
- Recalling firm
- FX SHOULDER
- Address 1
- 13465 Midway Rd Ste 310 13465 Midway Rd
- Address 2
- Ste 310
- City
- Dallas
- State
- TX
- Postal code
- 75244-5183
- Additional info contact
- Matt Glaser 800-429-8965
- Reason for recall
- Centered glenosphere box may contain an eccentric glenosphere.
- Root cause description
- Labeling mix-ups
- Product quantity
- 4
- Distribution pattern
- US Nationwide distribution in the state of NJ.
- 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.
- K numbers
- K191146
- Harmonized identifiers (openFDA)
- Device name
- Shoulder Prosthesis, Reverse Configuration
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3660
- Device class
- 2
- K number
- K171789, K252404, K200895, K113121, K202098, K212415, K130895, K181611, K050315, K080642, K241043, K183077, K203694, K252352, K252516, K041873, K092900, K252788, K213117, K181999, K142863, K231445, K232265, K120374, K110708, K111735, K161742, K140082, K192799, K253624, K072804, K131575, K161120, K211991, K203755, K250338, K132285, K140478, K152754, K260102 +167 more
- Registration number
- 8010916, 1043534, 1835444, 3008534770, 9617840, 3006563559, 3009923578, 3012544635, 3014128390, 3004748528, 8010379, 3011274144, 3009423112, 3009555440, 3017036078, 3010065126, 1834379, 1219655, 3006272282, 3009971621, 1526534, 3007441485, 1529009, 3003403260, 3011500362, 3006017180, 3010009693, 1836357, 9616671, 1423662, 3005562917, 3008421730, 3009532798, 3010370880, 3008388276, 3004153896, 3019269298, 1450662, 3010386387, 2528981 +153 more
- FEI number
- 3003386935, 1043534, 3002807830, 3002807036, 3003064967, 3008534770, 1000220733, 3006563559, 3009923578, 3012544635, 3014128390, 3004748528, 3011274144, 3009423112, 3009555440, 3017036078, 3001814066, 1000306431, 3010065126, 1219655, 3006272282, 1000116116, 1526534, 3009971621, 3007441485, 3001452082, 3003403260, 3002854251, 3011500362, 3006017180, 3010009693, 3005562917, 3005233524, 3008421730, 3009532798, 3010370880, 3008388276, 3004153896, 3019269298, 3002924544 +153 more