Acetabular Pressurizer recall
Acetabular Pressurizer; single use and six units per box. The Acetabular Pressurizer 0206-522-000 is an accessory to the Advanced Cement Mixer (ACM).…
Why was Acetabular Pressurizer recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part number: 0206-522-000 and lots: 08183012, 08310012, 09237012, 10243012, 11109012, 11353012, and 12216012
- 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).…
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- 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.
- Recall date
- November 20, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)