Z-0280-2014Class II

Acetabular Pressurizer; single use and six units per box. The Acetabular Pressurizer 0206-522-000 is an...

Name: Z-0280-2014 Acetabular Pressurizer; single use and six units per box. The Acetabular Pressurizer 0206-522-000 is an...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2013-11-01
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2013-11-01 / Terminated / root cause: manufacturing process

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of 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... on 2013-11-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0280-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-01
Posted: 2013-11-14
Terminated: 2014-02-10
Recalling firm: Stryker Corp.
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.
Product code: JDZ Mixer, Cement, For Clinical Use
Reason for recall: 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
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Stryker Instruments, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated 11/01/2013, to all domestic consignees/customers and an email was sent to the International Subsidiaries and Sales Representatives. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1. Immediately review this Recall Notification 2. Immediately check all stock areas and/or operating room storage and quarantine any affected product found. 3. Complete the enclosed Business Reply Form to confirm receipt of this notification and identify how many, if any, affected items are currently in your inventory. Please complete and return the Business Reply Form even if you don't have any affected product on hand. Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in this Notification. 4. If you have further distributed this product, please forward this letter and the attached Business Reply Form (BRF) to all affected locations. Please indicate each location on the BRF. 5. Fax the completed Business Reply Form to Stryker Instruments Regulatory Department, 866-521-2762. 6. Upon receipt of the Business Reply Form, if you have recalled product on hand, Stryker will email a pre-paid shipper. This shipper can be used to return the recalled Acetabular Pressurizers to Stryker. 7. Upon receipt of recalled Acetabular Pressurizers, credit will be applied to your account. For questions regarding this recall please contact Stryker Instruments: Monday-Friday 8am-5pm (EST) at 269-389-2921 or email: [email protected].
Quantity in commerce: 87 boxes (522 each)
Distribution: Worldwide distribution: US (nationwide) including states of: TX, FL, IL, IA, ND, WI, VA, and NJ.; and countries of: CANADA, POLAND and SWITZERLAND.
Product codes and lots: Part number: 0206-522-000 and lots: 08183012, 08310012, 09237012, 10243012, 11109012, 11353012, and 12216012

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0280-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0280-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-14

Product code JDZ

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)