Z-2712-2018Class II
#3 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of...
Howmedica Osteonics Corp / initiated 2017-10-24 / Terminated
Howmedica Osteonics Corp. began a recall of #3 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and... on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-2712-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Howmedica Osteonics Corp
- Product
- #3 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
- Product code
- KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
- 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 root cause
- Under Investigation by firm
- Action
- 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
- Quantity in commerce
- 999
- Distribution
- Distribution US Nationwide.
- Product codes and lots
- RCN-H3
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2663-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2664-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2665-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2666-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2667-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2668-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2669-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2670-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2671-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2672-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2673-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2674-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2675-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2676-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2677-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2678-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2679-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2680-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2681-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2682-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2683-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2684-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2685-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2686-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2687-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2688-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2689-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2690-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2691-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2692-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2693-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2694-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2695-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2696-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2697-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2698-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2699-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2700-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2701-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2702-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2703-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2704-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2705-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2706-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2707-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2708-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2709-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2710-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2711-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2712-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2713-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2714-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2715-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2716-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2717-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2718-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2719-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2720-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2721-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2722-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2723-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2724-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2725-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2726-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2727-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2728-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2729-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2730-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2731-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2732-2018 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.