Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 24, 2016
Stryker AutoPlex System. Model Numbers 0607-687-000, 0605-887-000, 0605-687-000, and 0605-683-000. For bone cement. Stryker AutoPlex System kits contain a cement mixer, cement injector, funnel, and an extension tube assembly whereby bone cement powder and liquid monomer are mixed inside a chamber and transferred into a cement injector automatically. The bone cement is then dispensed directly into a fracture site using the cement injector and introducer needle combination.
The Piston Head can become separated from the Delivery Piston, blocking the injection assembly Valve resulting in a cement backflow towards the injector handle. Potential for del…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Stryker Instruments Div. of Stryker Corporation recalled Stryker AutoPlex System. Model Numbers 0607-687-000, 0605-887-000, 0605-687-000, and 0… - a moderate-severity action.
Stryker AutoPlex System. Model Numbers 0607-687-000, 0605-887-000, 0605-687-000, and 0… was recalled by Stryker Instruments Div. of Stryker Corporation in August 24, 2016. Reason: The Piston Head can become separated from the Delivery Piston, blocking the injection assembly Valve resultin…. Check the official notice for the remedy. Verify recall #Z-2536-2016 with the FDA Devices before acting.
The recall
Stryker Instruments Div. of Stryker Corporation issued this moderate-severity FDA Devices recall-The Piston Head can become separated from the Delivery Piston, blocking the injection assembly Valve resultin….
- Moderate
- severity level
- Class II
- classification
- August 24, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2536-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2536-2016) was formally reported on August 24, 2016, with the manufacturer initiating the action on June 14, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Stryker Instruments Div. of Stryker Corporation is listed as the recalling firm, operating out of Portage, MI. Federal records list the affected scope as 4,841 boxes (9,682 units).
The documented reason for this recall is: The Piston Head can become separated from the Delivery Piston, blocking the injection assembly Valve resulting in a cement backflow towards the injector handle. Potential for delay in surgery if additional cement needs… Distribution data in the federal record shows the product reached: Worldwide distribution. US nationwide, France, Netherlands, Spain, Italy, Canada, Israel, Romania, Switzerland, and United Kingdom.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
4,841 boxes (9,682 units)
Related Recalls
6
3 from same agency
Product description
Stryker AutoPlex System. Model Numbers 0607-687-000, 0605-887-000, 0605-687-000, and 0605-683-000. For bone cement. Stryker AutoPlex System kits contain a cement mixer, cement injector, funnel, and an extension tube assembly whereby bone cement powder and liquid monomer are mixed inside a chamber and transferred into a cement injector automatically. The bone cement is then dispensed directly into a fracture site using the cement injector and introducer needle combination.
Reason for recall
The Piston Head can become separated from the Delivery Piston, blocking the injection assembly Valve resulting in a cement backflow towards the injector handle. Potential for delay in surgery if additional cement needs to be prepared for the injection procedure.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2536-2016 |
| Date reported | August 24, 2016 |
| Date initiated | June 14, 2016 |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation |
| Firm location | Portage, MI |
| Affected scope | 4,841 boxes (9,682 units) |
| Distribution | Worldwide distribution. US nationwide, France, Netherlands, Spain, Italy, Canada, Israel, Romania, Switzerland, and United Kingdom. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2536-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Stryker AutoPlex System. Model Numbers 0607-687-000, 0605-887-000, 0605-687-000, and 0605-683-000. For bone cement. Stryker AutoPlex System kits contain a cement mixer, cement injector, funnel, and an extension tube assembly whereby bone cement powder and liquid monomer are mixed inside a chamber and transferred into a cement injector automatically. The bone cement is then dispensed directly into a fracture site using the cement injector and introducer needle combination.. Recalled by Stryker Instruments Div. of Stryker Corporation. Units affected: 4,841 boxes (9,682 units).
Why was this product recalled? ▼
The Piston Head can become separated from the Delivery Piston, blocking the injection assembly Valve resulting in a cement backflow towards the injector handle. Potential for delay in surgery if additional cement needs to be prepared for the injection procedure.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 24, 2016. Severity: Moderate. Recall number: Z-2536-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution. US nationwide, France, Netherlands, Spain, Italy, Canada, Israel, Romania, Switzerland, and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2536-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 24, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.