Z-1443-2010

Literature for Implant Extraction Set - Implant Extraction Guide Module One & Two. Lists and describes the...

Name: Z-1443-2010 Literature for Implant Extraction Set - Implant Extraction Guide Module One & Two. Lists and describes the...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2010-03-02
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2010-03-02 / Terminated / root cause: labeling and UDI

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Literature for Implant Extraction Set - Implant Extraction Guide Module One & Two. Lists and describes the instruments which are in the Implant Extraction Set... on 2010-03-02. The reason FDA records is "Literature did not include the design change to a smaller cannulation diameter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1443-2010
Status: Terminated
Initiated: 2010-03-02
Posted: 2010-04-27
Terminated: 2012-08-06
Recalling firm: Howmedica Osteonics Corp
Product: Literature for Implant Extraction Set - Implant Extraction Guide Module One & Two. Lists and describes the instruments which are in the Implant Extraction Set and the general application of these instruments for hardware removal.
Product code: HWB Extractor
Reason for recall: Literature did not include the design change to a smaller cannulation diameter.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: An Urgent Correction - Operative Technique letter was sent to direct accounts, Hospital Risk Management, Chief of Orthopaedics and Surgeons that use the Gamma3 system. Notification letters were sent via Federal Express on March 2, 2010. The letter identified the product and described the issue. It also discussed the potential hazards and risk mitigation. Customers are to contact Customer Service at 1-866-OR-ASSIST or any of the other firm representatives listed in the letter.
Quantity in commerce: 790 unit
Distribution: Nationwide Distribution
Product codes and lots: LIES-OT

Product code HWB

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)