Agency classClass IIOur severity:Severe FDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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…
Manufacturer: Stryker Instruments Div. of Stryker Corporation
Category: Medical Device — Surgical Instrument
Hazard: structural-defect
component-release

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:

Same manufacturer · Stryker Instruments Div. of Stryker Corporation

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