Addison, TX, United States
Osteomed, LLC recalls
3 recalls recorded since 2018, most recently on 31 May 2023. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 31 May 2023
- Reason
- Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, KS, KY, MD, MO, MT, NE, NY, TN, TX and the country of SG.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2107-2023, Z-2108-2023
- REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
- REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile
Ongoing Class II Medical devices
- Recall started
- 28 October 2021
- Reason
- Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, Guam, HI, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA and WI. The countries of Argentina, Bolivia, Brazil, Canada, Chile, Colo
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0335-2022
- OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power
Terminated Class II Medical devices
- Recall started
- 2 April 2020
- Terminated
- 5 May 2021
- Reason
- Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
- 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, ITA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2181-2020, Z-2188-2020, Z-2189-2020, Z-2182-2020, Z-2184-2020, Z-2183-2020, Z-2190-2020, Z-2191-2020, Z-2180-2020, Z-2187-2020, Z-2185-2020, Z-2186-2020
- OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
- OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
- 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.
- OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
- OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
- OSTEOVATION 5CC INJECT FORMULA. REF/UDI: 390-2005/00813845020054 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
- OSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /00813845021092 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
- OSTEOVATION RMX 10 CC Injectable. REF/UDI: 390-6002/ /00813845021099 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
- and 4 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.