OSTEOVATION RMX Injectable BVF 5CC . REF/UDI: 390-6001/ /00813845021082 - Product Usage: The product provides a bone voi
FDA device recall Z-2189-2020 · posted 2020-05-29 · Terminated
Recall details
- Recalling firm
- Osteomed, LLC
- Reason for recall
- Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
- Action taken
- On 04/02/2020, an URGENT Medical Device Recall letter was sent to all consignees affected by the recall. OsteoMed has requested that affected customers: (1) review this letter in full, review current inventory, and complete and return the Acknowledgement and Receipt Form via email or fax; and (2) return unused inventory via Federal Express (using OsteMed account)
- Root cause
- Vendor change control
- Status
- Terminated
- Product code
- MQV
- Quantity affected
- 278
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA. MA, MD, ME. MI, MO, MS, MT, NC, ND, NE, NH, NJ, N
- Date initiated
- 2020-04-02
- Date posted
- 2020-05-29
- Date terminated
- 2021-05-05
- Location
- Addison, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OSTEOVATION CMF BONE VOID FILLER (K051784) | Skeletal Kinetics, LLC | 2005-07-20 |