Z-1198-2012

Flat Proximal Pressurizer. Bone cement pressurizers are intended to help seal the delivery path between the...

Name: Z-1198-2012 Flat Proximal Pressurizer. Bone cement pressurizers are intended to help seal the delivery path between the...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2012-01-13
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2012-01-13 / Terminated / root cause: labeling and UDI

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Flat Proximal Pressurizer. Bone cement pressurizers are intended to help seal the delivery path between the delivery nozzle and bone in order to pressurize the... on 2012-01-13. The reason FDA records is "The firm identified two complaints have been reported indicating that the product inside the package did not match with the label information. The product was labeled as Flat Proximal Pressurizer P/N 0206-556-000 while...". 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-1198-2012
Status: Terminated
Initiated: 2012-01-13
Posted: 2012-03-12
Terminated: 2013-07-24
Recalling firm: Stryker Corp.
Product: Flat Proximal Pressurizer. Bone cement pressurizers are intended to help seal the delivery path between the delivery nozzle and bone in order to pressurize the cement during delivery.
Product code: KIH Dispenser, Cement
Reason for recall: The firm identified two complaints have been reported indicating that the product inside the package did not match with the label information. The product was labeled as Flat Proximal Pressurizer P/N 0206-556-000 while the product inside the package was Femoral Pressurizer P/N 0206-566-000.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: Stryker Instruments sent an "Urgent Medical Device Recall notification" dated January 13, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to : Immediately check all stock areas or operating room storage and quarantine any affected product found. Mark product as RECALLED PRODUCT. Please indicate on the BRF the quantity of affected Pressurizers you are returning and fill in the form completely. Sign the BRF (even if you do not have any affected product). Note: Your signature on the BRF indicates that you received and understand this notification and are returning all affected product from your facility. Fax the Business Reply Form to Stryker Instruments Regulatory Department, 866-521-2762. Upon receipt of the BRF, Stryker will contact you to coordinate the return of all affected product that you have on hand. Send back all affected product using the pre-paid shipper provided to you by Stryker. Upon receipt of the product, a replacement will be issued to your account
Quantity in commerce: 10 boxes (60 units)
Distribution: Worldwide Distribution -- Nationwide, including the states of AL and OK and the country of Canada.
Product codes and lots: Part Number: 0206-556-000; Lot: 11271012

Product code KIH

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)