Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral Assembly, rHead Rad
FDA device recall Z-0098-2014 · posted 2013-10-29 · Terminated
Recall details
- Recalling firm
- Small Bone Innovations, Inc.
- Reason for recall
- The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box.
- Action taken
- Email correspondence and a notification letter, dated September 6, 2013, were sent to users requesting the immediate return of affected devices. Another notification letter, dated December 20, 2013 was also sent for recall of the additional devices after the recall was expanded.
- Root cause
- Packaging change control
- Status
- Terminated
- Product code
- KWI
- Quantity affected
- 2036 devices
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Canada and Mexico.
- Date initiated
- 2013-09-06
- Date posted
- 2013-10-29
- Date terminated
- 2015-03-30
- Location
- Morrisville, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SBI LATERAL RADIO CAPITELLUM (K070236) | Small Bone Innovations, Inc. | 2007-02-21 |
| SBI LATERAL RHEAD IMPLANT (K062898) | Small Bone Innovations, Inc. | 2006-11-13 |
| RADIAL HEAD IMPLANT (K011819) | Avanta Orthopaedics, Inc. | 2001-06-19 |
| ULNAR HEAD IMPLANT (K010786) | Avanta Orthopaedics, Inc. | 2001-04-11 |
| RADIAL HEAD IMPLANT (K002644) | Avanta Orthopaedics, Inc. | 2000-11-20 |
| RADIAL HEAD IMPLANT (K982288) | Avanta Orthopaedics, Inc. | 1998-09-08 |