Modular Replacement System with Extra-Cortical Porous Coating, Femoral Module Stem and Tibial Module Stem
This recall has been terminated (originally issued February 27, 2003).
- Company
- Stryker Howmedica Osteonics
- Recall Initiated
- January 7, 2003
- Posted
- February 27, 2003
- Terminated
- July 31, 2003
- Recall Number
- Z-0588-03
- Quantity
- 311
- Firm Location
- Mahwah, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Some components have disassociated post-operatively resulting in additional surgery to the patient.
Distribution
The devices were distributed nationwide to Howmedica branches/agents, hospitals, one government hospital and internationally.
Lot / Code Info
Catalog No. Lot No. Description 6485-3-008 D6JC SMALL FEMORAL STEM SECTION 8MM X 102MM; 6485-3-011 D6CDA FEMORAL MODULE STEM SECTION 11MM X 127MM; 6485-3-011 D6CDE FEMORAL MODULE STEM SECTION 11MM X 127MM; 6485-3-011 D6CDF FEMORAL MODULE STEM SECTION 11MM X 127MM; 6485-3-011 D6CEA FEMORAL MODULE STEM SECTION 11MM X 127MM; 6485-3-013 D6ADA FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6ADB FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6ADC FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CFA FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CFD FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CFF FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CFH FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CFI FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CFJ FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CFK FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CGA FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CGF FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6NJA FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6NKB FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6NKC FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6NKD FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-015 D6CHA FEMORAL MODULE STEM SECTION 15MM X 127MM; 6485-3-015 D6CHC FEMORAL MODULE STEM SECTION 15MM X 127MM; 6485-3-015 D6CHE FEMORAL MODULE STEM SECTION 15MM X 127MM; 6485-3-015 D6CHF FEMORAL MODULE STEM SECTION 15MM X 127MM; 6485-3-015 D6GRB FEMORAL MODULE STEM SECTION 15MM X 127MM; 6485-3-015 D6GRC FEMORAL MODULE STEM SECTION 15MM X 127MM; 6485-3-015 D6GRD FEMORAL MODULE STEM SECTION 15MM X 127MM; 6485-3-015 D6GRE FEMORAL MODULE STEM SECTION 15MM X 127MM; 6485-3-017 D5YEF FEMORAL MODULE STEM SECTION 17MM X 127MM; 6485-3-311 D5YKAA FEMORAL MODULE 11MM X 203MM CURVED LONGSTEM; 6485-3-311 D5YKAB FEMORAL MODULE 11MM X 203MM CURVED LONGSTEM; 6485-3-311 D5YKAC FEMORAL MODULE 11MM X 203MM CURVED LONGSTEM; 6485-3-313 D6CBA FEMORAL MODULE 13MM X 203MM CURVED LONGSTEM; 6485-6-409 D5GBE TIBIAL MODULE STEM SECTION 9MM X 127MM; 6485-6-411 D5XWA TIBIAL MODULE STEM SECTION 11MM X 127MM.
Root Cause
Other
Action Taken
Notification letters were sent to Howmedica sales agents and Operating Room Supervisors via FedEx on 1/7/2003. On 2/12/2003, Howmedica again sent out notification letters on the extended recalled devices.