Z-0582-2014Class II

Stryker Orthopaedics Rim Impactor Tip

Name: Z-0582-2014 Stryker Orthopaedics Rim Impactor Tip
Creator: Stryker Howmedica Osteonics Corp.
Published: 2013-09-30
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2013-09-30 / Terminated / root cause: design

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery on 2013-09-30. FDA classified it as Class II and gives the reason as "Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0582-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-30
Posted: 2013-12-27
Terminated: 2016-10-19
Recalling firm: Howmedica Osteonics Corp
Product: Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery.
Product code: HWA Impactor
Reason for recall: Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments.
Root cause tag: design
FDA root cause: Device Design
Action: Stryker sent an Urgent Medical Device Correction letter dated October 1, 2013 to all affected customers via Fed Ex. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and fax the attached Product Correction Acknowledgement form to 855-251-3635.
Quantity in commerce: 1,690 units
Distribution: USA Nationwide Distribution
Product codes and lots: Catalog number 12350-013 all lot codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0582-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0582-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-01	2013-12-26
Z-0583-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-01	2013-12-26

Product code HWA

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)