Recall Z-2189-2020
Osteomed, LLC · initiated April 2, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
OSTEOVATION RMX Injectable BVF 5CC . REF/UDI: 390-6001/ /00813845021082 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Codes / lots: LOT 1125793, 1129602, 1132492, 1132347, 1134448, 1137064 and 1142080
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.
FDA-determined cause: Vendor change control
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)
Details
- Recall number
- Z-2189-2020
- Initiated
- April 2, 2020
- Posted by FDA
- May 29, 2020
- Terminated
- May 5, 2021
- Product code
- MQV – Filler, Bone Void, Calcium Compound
- Quantity
- 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, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY and the countries of AUSTRALIA, ITALY, KOREA, MALAYSIA, PERU, SINGAPORE and THAILAND.
- Recalling firm
- Osteomed, LLC, Addison, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2180-2020 Class II | OSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - Product Usage: The…Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for… | 04/02/2020Terminated |
| Z-2181-2020 Class II | OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product Usage: The…Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for… | 04/02/2020Terminated |
| Z-2182-2020 Class II | OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product Usage: The…Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for… | 04/02/2020Terminated |
| Z-2183-2020 Class II | OSTEOVATION 5CC INJECT FORMULA. REF/UDI: 390-2005/00813845020054 - Product Usage: The…Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for… | 04/02/2020Terminated |
| Z-2184-2020 Class II | OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The…Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for… | 04/02/2020Terminated |
| Z-2185-2020 Class II | OSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - Product Usage: The…Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for… | 04/02/2020Terminated |
| Z-2186-2020 Class II | OSTEOVATIONEX 3CC IMPACTFORMULA. REF/UDI: 390-0203/00813845020030 - Product Usage: The…Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for… | 04/02/2020Terminated |
| Z-2187-2020 Class II | OSTEOVATION 3CC IMPACTFORMULA. REF/UDI: 390-2103/00813845020078 - Product Usage: The…Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for… | 04/02/2020Terminated |
| Z-2188-2020 Class II | OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The…Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for… | 04/02/2020Terminated |
| Z-2190-2020 Class II | OSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /00813845021092 - Product Usage:…Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for… | 04/02/2020Terminated |
| Z-2191-2020 Class II | OSTEOVATION RMX 10 CC Injectable. REF/UDI: 390-6002/ /00813845021099 - Product Usage:…Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for… | 04/02/2020Terminated |