Z-0828-2016Class II

Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS...

Name: Z-0828-2016 Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS...
Creator: Stryker Spine
Published: 2015-12-18
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2015-12-18 / Terminated / root cause: manufacturing process

FDA source

Stryker Spine began a recall of Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS France Used to facilitate insertion of the Aero-AL... on 2015-12-18. FDA classified it as Class II and gives the reason as "Reported jamming of the impaction handle when assembled to the Inserter guide at the threads". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0828-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-18
Posted: 2016-02-19
Terminated: 2016-08-01
Recalling firm: Howmedica Osteonics Corp
Product: 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.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Reported jamming of the impaction handle when assembled to the Inserter guide at the threads.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Stryker Spine sent Urgent Product Removal notification letters to branches/agencies on 12/18/2015 via FedEx. The letters provided a description of the affected product, the issue, potential hazards and risk mitigations, and actions to be taken. Customers were asked to examine their inventory and hospital locations to identify the product and reconcile with the affected catalog and lot numbers provided. The Customer Response Form and Product Quantity Tracking Spreadsheet for Health Care Facilities should be completed and returned within five days of receipt of the notice to the e-mail or fax number provided. Questions can be directed to Nabil Riaz - Regulatory Compliance Specialist, Regulatory Compliance & Quality Systems at [email protected].
Quantity in commerce: 31 units
Distribution: Nationwide Distribution
Product codes and lots: Lot #144933, 14D252, and 14D253.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0828-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0828-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-19

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)