—#139928

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.

FDA product code: MNI — Orthosis, Spinal Pedicle Fixation
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K020517
Affected lot / code info: 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.

Why it was recalled

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).

Root cause (FDA determination)

Process control

Action the firm took

An Urgent Notice: Medical Device Recall, dated September 4, 2015, was sent to end users to alert them about the issue and possible risk to patients. Customers were requested to follow the actions to be taken for if they have affected product or not; complete the response form, and return affected product. Customers can call 610-719-5450 or a local Synthes Sales Consultant with any questions.

Recalling firm

Firm: Synthes (USA) Products LLC
Address: 1301 Goshen Pkwy, West Chester, Pennsylvania 19380-5986

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2015-09-04
Posted by FDA: 2015-10-17
Terminated: 2016-08-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #139928. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.