FDA Device recall Z-0280-2014
Acetabular Pressurizer
- FDA Device
- Class II
- terminated
- Published 2013-11-20
On 2013-11-20 the FDA classified a Class II recall of Acetabular Pressurizer by Stryker Instruments Div, citing 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 pla….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0280-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-01 |
| Published | 2013-11-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Instruments Div |
| Distribution | US |
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
Identifiers
| code_info | Part number: 0206-522-000 and lots: 08183012, 08310012, 09237012, 10243012, 11109012, 11353012, and 12216012 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0280-2014%22
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