CLASS II Device recall · Reported 28 Oct 2015 · FDA Enforcement Report
Unit Rod Unit Rod Unit Rod Unit Rod Unit Rod Unit Rod Unit recalled
Synthes (USA) Products is recalling Unit Rod Unit Rod Unit Rod Unit Rod Unit Rod Unit Rod Unit Rod Unit Rod Unit Rod Unit Rod, distributed nationwide in the US. The recall was initiated on 4 Sep 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0134-2016
- FDA event ID
- 72134
- Recalling firm
- Synthes (USA) Products, West Chester, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Sep 2015
- FDA classified
- 16 Oct 2015
- Reported
- 28 Oct 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 4 Sep 2015 | Recall initiated by company | |
| 16 Oct 2015 | Classified by FDA | +42 days |
| 28 Oct 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution
Questions about this recall
Is Unit Rod Unit Rod Unit Rod Unit Rod Unit Rod Unit Rod Unit Rod Unit Rod Unit Rod Unit Rod recalled?
Yes. Synthes (USA) Products recalled Unit Rod Unit Rod Unit Rod Unit Rod Unit Rod Unit Rod Unit Rod Unit Rod Unit Rod Unit Rod on 4 Sep 2015. The recall is Class II and its status is Terminated. Recall number Z-0134-2016.
Why was it 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).
Which lots are affected?
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.
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Synthes (USA) Products
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|---|---|---|---|---|---|
| Device | CLASS II | 4 Volt(tm) Tap Cortex Screw To recalled by Synthes (USA) Products | Synthes (USA) Products | Other | Nationwide |
| Device | CLASS II | 4 Volt Tap Locking Screw Tap To recalled by Synthes (USA) Products | Synthes (USA) Products | Other | Nationwide |
| Device | CLASS II | Low Prof Lckng Screw, F/im Nail / L / Xl25/ Ster recalled | Synthes (USA) Products | Packaging Defects | Nationwide |
| Device | CLASS II | Low Prof Lckng Screw, F/im Nail / L / Xl25/ Ster recalled | Synthes (USA) Products | Packaging Defects | Nationwide |
| Device | CLASS II | Stardrive Scrwdrvr Shft/T4/Self-retaining/Hxc-Intended recalled | Synthes (USA) Products | Other | Nationwide |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |