The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0286-2013·Announced 2012-11-21

Stryker Recalls Peri-Acetabular Prosthesis Femoral Extension Components

Stryker Howmedica Osteonics is recalling 301 units of Peri-Acetabular Prosthesis V40 Femoral Extension Components due to insufficient taper torsional strength when used with forged CoCr stems.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a structural defect in a medical device (insufficient torsional strength) which poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Stryker Howmedica Osteonics Corp. is recalling 301 units of the Special Orthopaedic Solution Peri-Acetabular Prosthesis V40 Femoral Extension Component. These components are used in the Peri-Acetabular Reconstruction (PAR) endoprosthesis, which is designed for patients requiring reconstruction of large acetabular defects after a Type I and II pelvic resection.

The recall was initiated because Stryker became aware that insufficient taper torsional strength may result when a PAR extension piece is used with a forged CoCr stem. This potential mechanical weakness could compromise the structural integrity of the implant assembly.

The affected units were distributed worldwide and nationwide in the US. The source text does not specify the number of patients affected or report any specific injuries or illnesses. Healthcare providers and patients should contact Stryker Howmedica Osteonics for further instructions regarding the use of these components.

The recalled product

Product
Special Orthopaedic Solution Peri-Acetabular Prosthesis V40 Femoral Extension Component Product Usage: The PAR extension piece is a component of the PAR assembly. The Peri-Acetabular Reconstruction (PAR) endoprosthesis was developed to meet the unique needs of patients…
Manufacturer
Stryker Howmedica Osteonics Corp.
Category
Medical Device — Orthopaedic Implant
Hazard
Affected units
301

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 (10)

  • 40MM C-KM28-4-202 RX2842C PAR FEM EXT V-40
  • 50MM C-KM28-4-203 RX2842D PAR FEM EXT V-40
  • 60MM C-KM28-6-901 RX2869B PAR FEM EXT V-40
  • 40MM C-KM28-6-902 RX2869C PAR FEM EXT V-40
  • 50MM C-KM28-6-903 RX2869D PAR FEM EXT V-40
  • 60MM C-KM28-7-801 RX2878B PAR FEM EXT V-40
  • 50MM C-KM29-6-102 RX2961C PAR FEM EXT V-40
  • 60MM C-KM29-9-101 RX2991B PAR FEM EXT V-40
  • 50MM C-KM30-0-902 RX3009C PAR FEM EXT V-40
  • 60MM C-KM30-1-101 RX3011B PAR FEM EXT V-40

Distribution

Distributed nationwide across the United States.

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