CLASS II Device recall · Reported 2 Mar 2016 · FDA Enforcement Report

Stryker Aero-AL Impaction handle recalled by Stryker Spine

Stryker Spine is recalling Stryker Aero-AL Impaction handle, distributed nationwide in the US. The recall was initiated on 18 Dec 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #144933, 14D252, and 14D253.

Quantity recalled31 units

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-0828-2016
FDA event ID: 73180
Recalling firm: Stryker Spine, Allendale, NJ
Classification: Class II
Status: Terminated
Recall initiated: 18 Dec 2015
FDA classified: 19 Feb 2016
Reported: 2 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

18 Dec 2015	Recall initiated by company
19 Feb 2016	Classified by FDA	+63 days
2 Mar 2016	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

Reported jamming of the impaction handle when assembled to the Inserter guide at the threads.

Product as listed by the FDA

Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS France Used to facilitate insertion of the Aero-AL cage into the disc space.

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

Reported jamming of the impaction handle when assembled to the Inserter guide at the threads.

Which lots are affected?

Lot #144933, 14D252, and 14D253.

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 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.

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