CLASS II Device recall · Reported 7 Aug 2013 · FDA Enforcement Report
Synthes Synapse SD Drill Guide recalled by Synthes USA HQ
Synthes USA HQ is recalling Synthes Synapse SD Drill Guide, distributed in Pennsylvania. The recall was initiated on 12 Oct 2012 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-1821-2013
- FDA event ID
- 65668
- Recalling firm
- Synthes USA HQ, West Chester, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Oct 2012
- FDA classified
- 29 Jul 2013
- Reported
- 7 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Spinal Implants
Timeline
| 12 Oct 2012 | Recall initiated by company | |
| 29 Jul 2013 | Classified by FDA | +290 days |
| 7 Aug 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A complaint was received from the field, that the drill guide was etched incorrectly, 12mm etch instead of 18mm drill guide. The firm identified that this constituted a field action and retrospectively reported this action.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 Indicated for Hooks, Plate/Rods, Rods and Screws when intended to promote fusion of the cervical spine fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix; Axon and Synapse Systems are indicated for the following: -Degenerative Disk Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); -Spondylolisthesis; -Spinal Stenosis; -Fracture/dislocation; -Atlantoaxial fracture with instability; -Occipitocervical dislocation; -Revision of previous cervical spine surgery; and -Tumo
Where it was distributed
US distribution: PA only. .
Questions about this recall
Is Synthes Synapse SD Drill Guide recalled?
Yes. Synthes USA HQ recalled Synthes Synapse SD Drill Guide on 12 Oct 2012. The recall is Class II and its status is Terminated. Recall number Z-1821-2013.
Why was it recalled?
A complaint was received from the field, that the drill guide was etched incorrectly, 12mm etch instead of 18mm drill guide. The firm identified that this constituted a field action and retrospectively reported this action.
Which lots are affected?
Part Number SD389.477, Lot Number 6913900
Where was it sold?
US distribution: PA only. .
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 HQ
All 56| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Synthes Hand Switch - Electric Pen Drive recalled by Synthes USA HQ | Synthes USA HQ | Foreign Material | Nationwide |
| Device | CLASS II | Synthes TomoFix Plates The Synthes J5606-C TomoFix recalled | Synthes USA HQ | Other | Nationwide |
| Device | CLASS II | Synthes Trochanteric Fixation Nail As part of the Synthes recalled | Synthes USA HQ | Labeling Errors | Nationwide |
| Device | CLASS II | Synthes Soft Tissue Retractor Small Extendible recalled | Synthes USA HQ | Device Malfunction | Nationwide |
| Device | CLASS II | Titanium Trochanteric Fixation Nail recalled by Synthes USA HQ | Synthes USA HQ | 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 |