Device product
5.0mm Unit Rod 270mm, 5.0mm Unit Rod 290mm, 5.0mm Unit Rod 310mm, 5.0mm Unit Rod 330mm, 5.0mm Unit Rod 350mm, 5.0mm Unit Rod 370mm, 5.0mm Unit Rod 390mm, 5.0mm Unit Rod 410mm, 5.0mm Unit Rod 430mm, 5.0mm Unit Rod 450mm; Orthosis, Spinal, Pedicle fixation Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.
Z-0134-2016
Product summary
- Event
- Event 72134
- Status
- Terminated
- Classification
- Class II
- Quantity
- 492
- Official record key
device-enforcement:Z-0134-2016
Official wording
Reason: This product was produced using a finishing process not identified as part of the manufacturing specification. The process used with the lots subject to this Recall was a bead blast process. (Bead Blasting vs. Shot Peened).
Code information: Part numbers: 298.269 298.270 298.271 298.272 298.273 298.274 298.275 298.276 298.277 298.278 lot numbers: 4729951; 4841209; 4923651; 4923652; 4987688; 4987750; 5350635; 2002330; 3000595; 4729952; 4841210; 4923653; 4923654; 4987683; 4856248; 4987755; 5153848; 5153853; 1602596; 1880489; 4729953; 4841211; 4923666; 4923667; 4987778; 4856275; 4987761; 5159826; 5157329; 3016224; 4729954; 4841212; 4919162; 4923669; 4987779; 4856250; 4987766; 5153796; 3093619; 4729956; 4923674; 4987825; 4987780; 5066363; 4729958; 4923615; 4987826; 4987781; 5066364; 4729959; 4841213; 4923655; 4936270; 4987684; 4987771; 5153849; 5153854; 4729960; 4835367; 4923656; 4923657; 4984982; 4856246; 4987772; 5159827; 5157330; 4729961; 4835368; 4923658; 4923659; 4987685; 4856249; 4987773; 1602617; 3080451; 4729962; 4835378; 4919165; 4923660; 4987686; 4856252; 4987776; and 5153851.
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
This product was produced using a finishing process not identified as part of the manufacturing specification. The process used with the lots subject to this Recall was a bead blast process. (Bead Blasting vs. Shot Peened).