Recall Z-2667-2018
Howmedica Osteonics Corp. · initiated October 24, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Lat Assembly, Rad Stem Implant,Collar 6mm, Size1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Codes / lots: 310-0004
Reason for recall
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
FDA-determined cause: Under Investigation by firm
Action taken
On October 27, 2017 an URGENT MEDICAL RECALL NOTIFICATION was issued to customers titled Product Field Action PR 1642784. The letter requests that recipients notify all necessary individuals within their organization of the recall and that a Stryker trauma representative will collect any affected product from the customer location. Questions or concerns can be directed to 201-831-6693
Details
- Recall number
- Z-2667-2018
- Initiated
- October 24, 2017
- Terminated
- May 18, 2023
- Product code
- KWI – Prosthesis, Elbow, Hemi-, Radial, Polymer
- Quantity
- 170
- Distribution
- Distribution US Nationwide.
- Recalling firm
- Howmedica Osteonics Corp., Mahwah, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2663-2018 Class II | Lateral Assembly, Radial Implant, Size 1 Orthopedic implant for replacement of the…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | 10/24/2017Terminated |
| Z-2664-2018 Class II | Lateral Assembly, Radial Stem Implant, Size 2. Orthopedic implant for replacement of the…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | 10/24/2017Terminated |
| Z-2665-2018 Class II | Lateral Assembly, Radial Stem Implant, Size 3. Orthopedic implant for replacement of the…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | 10/24/2017Terminated |
| Z-2666-2018 Class II | Lateral Assembly, Radial Stem Implant, Size 4. Orthopedic implant for replacement of the…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | 10/24/2017Terminated |
| Z-2668-2018 Class II | Lat Assembly, Rad Stem Implant,Collar 6mm,Size 2. Orthopedic implant for replacement of…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | 10/24/2017Terminated |
| Z-2669-2018 Class II | Lat Assembly, Rad Stem Implant,Collar 6mm,Size 3. Orthopedic implant for replacement of…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | 10/24/2017Terminated |
| Z-2670-2018 Class II | Lat Assembly, Rad Stem Implant,Collar 6mm,Size 4. Orthopedic implant for replacement of…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | 10/24/2017Terminated |
| Z-2671-2018 Class II | Lateral Assembly, Radial Head Implant, Size 2. Orthopedic implant for replacement of the…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | 10/24/2017Terminated |
| Z-2672-2018 Class II | Lateral Assembly, Radial Head Implant, Size 3. Orthopedic implant for replacement of the…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | 10/24/2017Terminated |
| Z-2673-2018 Class II | Lateral Assembly, Radial Head Implant, Size 4. Orthopedic implant for replacement of the…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | 10/24/2017Terminated |
| Z-2674-2018 Class II | Lateral Assembly, Radial Head Impl Assembly, Size 2. Orthopedic implant for replacement…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | 10/24/2017Terminated |
| Z-2675-2018 Class II | Lateral Assembly, Radial Head Impl Assembly, Size 3. Orthopedic implant for replacement…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | 10/24/2017Terminated |
| Z-2676-2018 Class II | Lateral Assembly, Radial Head Impl Assembly, Size 4. Orthopedic implant for replacement…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | 10/24/2017Terminated |
| Z-2677-2018 Class II | rHead Stem Implant Plasma Coated, Size 1. Orthopedic implant for replacement of the…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | 10/24/2017Terminated |
| Z-2678-2018 Class II | rHead Stem Implant Plasma Coated, Size 2. Orthopedic implant for replacement of the…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | 10/24/2017Terminated |
| Z-2679-2018 Class II | rHead Stem Implant Plasma Coated, Size 3. Orthopedic implant for replacement of the…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | 10/24/2017Terminated |
| Z-2680-2018 Class II | rHead Stem Implant Plasma Coated, Size 4. Orthopedic implant for replacement of the…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | 10/24/2017Terminated |
| Z-2681-2018 Class II | rHead Stem Implant 6mm Collar, Size 1. Orthopedic implant for replacement of the…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | 10/24/2017Terminated |
| Z-2682-2018 Class II | rHead Stem Implant 6mm Collar, Size 2. Orthopedic implant for replacement of the…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | 10/24/2017Terminated |
| Z-2683-2018 Class II | rHead Stem Implant 6mm Collar, Size 3. Orthopedic implant for replacement of the…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | 10/24/2017Terminated |
| Z-2684-2018 Class II | rHead Stem Implant 6mm Collar, Size 4.Orthopedic implant for replacement of the proximal…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | 10/24/2017Terminated |
| Z-2685-2018 Class II | rHead Recon Stem Implant Plasma Coated, Size 1. Orthopedic implant for replacement of…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | 10/24/2017Terminated |
| Z-2686-2018 Class II | rHead Recon Stem Implant Plasma Coated, Size 2. Orthopedic implant for replacement of…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | 10/24/2017Terminated |
| Z-2687-2018 Class II | rHead Recon Stem Implant Plasma Coated, Size 3. Orthopedic implant for replacement of…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | 10/24/2017Terminated |
| Z-2688-2018 Class II | rHead Recon Stem Implant Plasma Coated, Size 4. Orthopedic implant for replacement of…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | 10/24/2017Terminated |
| Z-2689-2018 Class II | rHead Recon Stem Implant 6mm Collar,Size 1. Orthopedic implant for replacement of the…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | 10/24/2017Terminated |
| Z-2690-2018 Class II | rHead Recon Stem Implant 6mm Collar, Size 2. Orthopedic implant for replacement of the…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | 10/24/2017Terminated |
| Z-2691-2018 Class II | rHead Recon Stem Implant 6mm Collar, Size 3. Orthopedic implant for replacement of the…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | 10/24/2017Terminated |
| Z-2692-2018 Class II | rHead Recon Stem Implant 6mm Collar, Size 4. Orthopedic implant for replacement of the…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | 10/24/2017Terminated |
| Z-2693-2018 Class II | Radio Capitellum Large, Left Orthopedic implant for replacement of the proximal end of…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | 10/24/2017Terminated |