—#106727

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.

FDA product code: KIH — Dispenser, Cement
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Part Number: 0206-556-000; Lot: 11271012

Why it was recalled

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 (FDA determination)

Mixed-up of materials/components

Action the firm took

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

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E Milham Ave, Portage, Michigan 49002-9704

Distribution

Distribution pattern: Worldwide Distribution -- Nationwide, including the states of AL and OK and the country of Canada.

Timeline

Recall initiated: 2012-01-13
Posted by FDA: 2012-03-12
Terminated: 2013-07-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #106727. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.