FDA Device recall Z-0286-2013
Special Orthopaedic Solution Peri-Acetabular Prosthesis V40 Femoral Extension Component Product Usage: The PAR extension piece is a compone…
- FDA Device
- Class II
- terminated
- Published 2012-11-21
On 2012-11-21 the FDA classified a Class II recall of Special Orthopaedic Solution Peri-Acetabular Prosthesis V40 Femoral Extension Component Product Usage: The PAR extension piece is a compone… by Stryker Howmedica Osteonics, citing stryker has become aware that insufficient taper torsional strength may result when a PAR extension piece is used with a forged CoCr stem.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0286-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-16 |
| Published | 2012-11-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Howmedica Osteonics |
| Distribution | US |
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 who require reconstruction of large acetabular defects after a Type I and II pelvic resection.
Reason
Stryker has become aware that insufficient taper torsional strength may result when a PAR extension piece is used with a forged CoCr stem.
Identifiers
| code_info | Multiple codes C-2051-7-004 RX00138D FEMORAL PELVIC EXTENSION C-2052-5-004 RX00146D FEMORAL PELVIC EXTENSION C-HM42-…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 RX28 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0286-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.