The Recall Desk
SevereFDA (Devices)·Z-0280-2014·Announced 2013-11-20

Stryker Recalls Acetabular Pressurizers Due to Cracked Assemblies

Stryker is recalling 87 boxes of Acetabular Pressurizers because cracked assemblies may release during cement application.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (cracked assemblies) in a medical device used during surgery, which poses a risk of component release during use.

Plain-English summary

Stryker Instruments Division of Stryker Corporation is recalling 87 boxes (522 units) of Acetabular Pressurizers (P/N 0206-522-000). The product is a single-use accessory used to pressurize cement during surgery. The recall covers specific lots: 08183012, 08310012, 09237012, 10243012, 11109012, 11353012, and 12216012.

The recall was initiated after a manufacturing operator noticed cracked assemblies on March 15, 2013, before the product was sealed. The source states that a cracked tiplet may release from the hub during cement application due to injection pressure. The affected units were distributed worldwide, including the United States, Canada, Poland, and Switzerland.

Healthcare providers and patients should stop using the affected Acetabular Pressurizers and contact Stryker for instructions on returning the product. The recall is classified as Class II by the FDA.

The recalled product

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 0206-52
Manufacturer
Stryker Instruments Div. of Stryker Corporation
Category
Medical Device — Surgical Instrument
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • Part number: 0206-522-000 and lots: 08183012
  • 08310012
  • 09237012
  • 10243012
  • 11109012
  • 11353012
  • and 12216012

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Related recalls

Same manufacturer · Stryker Instruments Div. of Stryker Corporation

See all →

Same hazard · structural defect

See all →