Synthes (USA) Products LLC: Medical Device Recall in 2015 - (Recall #: Z-0134-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 4, 2015

Date Posted: October 28, 2015

Recall Number: Z-0134-2016

Event ID: 72134

Reason for Recall:

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).

Status: Terminated

Product Quantity: 492

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

Voluntary or Mandated:

Voluntary: Firm initiated