Special Orthopaedic Solution Peri-Acetabular Prosthesis V40 Femoral Extension Component Product Usage: The…
Medical device recall Z-0286-2013. Published in FDA’s Enforcement Report on Nov 21, 2012.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 21, 2012. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 301 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Stryker has become aware that insufficient taper torsional strength may result when a PAR extension piece is used with a forged CoCr stem.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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 who require reconstruction of large acetabular defects after a Type I and II pelvic resection.
301 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Multiple codes C-2051-7-004 RX00138D FEMORAL PELVIC EXTENSION C-2052-5-004 RX00146D FEMORAL PELVIC EXTENSION C-HM42-7-802 RX4278C 40MM EXT W/FEMALE V40 TAPER C-HM42-7-803 RX4278D 50MM EXT W/FEMALE V40 TAPER C-HM42-7-804 RX4278E 60MM EXT…
Every code shown here, 1,990 characters
Multiple codes C-2051-7-004 RX00138D FEMORAL PELVIC EXTENSION C-2052-5-004 RX00146D FEMORAL PELVIC EXTENSION C-HM42-7-802 RX4278C 40MM EXT W/FEMALE V40 TAPER C-HM42-7-803 RX4278D 50MM EXT W/FEMALE V40 TAPER C-HM42-7-804 RX4278E 60MM EXT W/FEMALE V40 TAPER C-HM49-4-401 RX4944B PAR 40MM EXT W/FEMALE V40 TAPE C-HM49-4-402 RX4944C PAR 50MM EXT W/FEMALE V40 TAPE C-HM49-4-403 RX4944D PAR 60MM EXT W/FEMALE V40 TAPE C-HM49-9-202 RX4992C PAR EXTENSION C-TAPER 40MM C-HM49-9-203 RX4992D PAR EXTENSION C-TAPER 50MM C-HM49-9-204 RX4992E PAR EXTENSION C-TAPER 60MM C-HM52-1-802 RX5218C PAR FEMORAL EXT V40 TAPER 40MM C-KM10-9-400 HG102AA FEMORAL PELVIC EXTENSION C-KM26-5-204 RX2652E PAR FEM EXT V-40, 40MM C-KM26-5-205 RX2652S PAR FEM EXT V-40 50MM C-KM26-5-206 RX2652T PAR FEM EXT V-40 60MM C-KM28-1-501 RX2815B PAR FEM EXT V-40, 40MM C-KM28-1-502 RX2815C PAR FEM EXT V-40 50MM C-KM28-1-503 RX2815D PAR FEM EXT V-40 60MM C-KM28-4-201 RX2842B PAR FEM EXT V-40, 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, 40MM C-KM28-7-802 RX2878C PAR FEM EXT V-40 50MM C-KM28-7-803 RX2878D PAR FEM EXT V-40 60MM C-KM29-6-101 KM2961B 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-KM29-9-102 RX2991C PAR FEM EXT V-40 60MM C-KM30-0-901 RX3009B 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, 50MM C-KM30-1-102 RX3011C PAR FEM EXT V-40 60MM C-KM32-0-801 RX3208B PAR FEM EXT V-40, 50MM C-KM32-0-802 RX3208C PAR FEM EXT V-40 60MM C-KM32-9-201 RX3292B 40MM EXT W/FEMALE V40 TAPER C-KM32-9-202 RX3292C 50MM EXT W/FEMALE V40 TAPER C-KM32-9-203 RX3292D 60MM EXT W/FEMALE V40 TAPER C-KM33-6-601 RX3366B 40MM EXT W/FEMALE V40 TAPER C-KM33-6-602 RX3366C 50MM EXT W/FEMALE V40 TAPER…
FDA’s list runs to 13,973 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - US Nationwide
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 16, 2012.
- FDA classified it on Nov 13, 2012.
- FDA’s Enforcement Report published it on Nov 21, 2012.
- FDA terminated it on Sep 9, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Stryker Howmedica Osteonics Corp., of Mahwah, NJ.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 13,973 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.