Recall Z-0280-2014 ยท JDZ Mixer, Cement, For Clinical Use
Stryker Instruments Div. of Stryker Corporation
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
| Date | Nov 14, 2013 (initiated Nov 1, 2013) |
| Status | Terminated |
| 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 |
| 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 ident |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.