FDAFDA · Food and drugs·Recall number Z-0280-2014
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.
Published November 20, 2013 · Recall initiated: November 1, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Distributor
- Worldwide distribution: US (nationwide) including states of: TX, FL, IL, IA, ND, WI, VA, and NJ.; and countries of: CANADA, POLAND and SWITZERLAND.
- Lot
- Part number: 0206-522-000 and lots: 08183012, 08310012, 09237012, 10243012, 11109012, 11353012, and 12216012
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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