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

FDA device recall Z-0280-2014 · posted 2013-11-14 · Terminated

Recall details

Recalling firm

Stryker Instruments Div. of Stryker Corporation

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

Action taken

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: kellyjo.whipple@stryker.com.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

JDZ

Quantity affected

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.

Date initiated

2013-11-01

Date posted

2013-11-14

Date terminated

2014-02-10

Location

Portage, MI