Recall Z-0280-2014— Stryker Instruments Div. of Stryker Corporation

Class II FDA medical device recall by Stryker Instruments Div. of Stryker Corporation, initiated 2013-11-01, terminated 2014-02-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Acetabular Pressurizer; single use and six units per box. The Acetabular Pressurizer 0206-522-000 is an accessory to the Advanced Cement Mixer (ACM). The Acetabular Pressurizer Tiplet P/N 0206-522-012 is sealed in a two pouches, sterilized, and labeled as part number 0206-522-000. This Acetabular Pressurizer is an accessory used to pressurize the cement applied to the prosthesis to be implanted during the surgery. The Acetabular Pressurizer is an injection molded component made with resin material DOW HDPD 10462N which is a rigid plastic once it is molded.. Reason: On March 14, 2013 a Work Order was opened for 120 units (20 boxes) of the Acetabular Pressurizer (P/N 0206-522-000 Rev. H). On March 15, 2013, when the product was going to be placed in the pouch to be sealed, the manufacturing operator noticed that some assemblies were cracked. As a result of the injection pressure of the cement gun, a cracked tiplet may release from the Hub during cement applica.

Recalling firm

Stryker Instruments Div. of Stryker Corporation

Classification

Class II

Status

Terminated

Initiated

2013-11-01

Terminated

2014-02-10

Firm location

Portage, MI, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.