CLASS I Device recall · Reported 28 Aug 2013 · FDA Enforcement Report
Stryker Oasys Midline Occiput Plate-1) Small Medium Large Long Mini recalled
Stryker Spine is recalling Stryker Oasys Midline Occiput Plate-1) Small Medium Large Long Mini, distributed nationwide in the US. The recall was initiated on 30 May 2013 and the FDA has classified it as Class I.
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-1976-2013
- FDA event ID
- 65777
- Recalling firm
- Stryker Spine, Allendale, NJ
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 30 May 2013
- FDA classified
- 22 Aug 2013
- Reported
- 28 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 30 May 2013 | Recall initiated by company | |
| 22 Aug 2013 | Classified by FDA | +84 days |
| 28 Aug 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body.
Product as listed by the FDA
Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.
Where it was distributed
Nationwide Distribution.
Questions about this recall
Why was it recalled?
Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body.
Which lots are affected?
K093670 Catalog numbers: Small - 48551044 Medium - 48551045 Large - 48551046 Large Long - 48551047 Mini- 48551048 All lots of the above
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 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 Stryker Spine
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Monterey AL Implant Inserter recalled by Stryker Spine | Stryker Spine | Other | 13 states |
| Device | CLASS II | Monterey AL Implant Inserter recalled by Stryker Spine | Stryker Spine | Other | 13 states |
| Device | CLASS II | Monterey AL Implant Inserter recalled by Stryker Spine | Stryker Spine | Other | 13 states |
| Device | CLASS II | Monterey AL Implant Inserter recalled by Stryker Spine | Stryker Spine | Other | 13 states |
| Device | CLASS II | AVS Anchor-C Cervical Cage System Instructions For Use recalled | Stryker Spine | Other | Nationwide |
Other Other Medical Devices recalls
All 13,884| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NOxBOXi Nitric Oxide Delivery System recalled | Noxbox | Device Malfunction | Nationwide |
| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |