Lower riskMedical device recall · FDA · Published April 2, 2020
Osteomed OSTEOVATIONEX 3CC Formula May Not Set Properly After Shelf-Life
Osteomed recalls OSTEOVATIONEX 3CC bone void filler kits that may not maintain setting characteristics for the labeled shelf-life. Affected kits have specific lot numbers.
“Osteomed OSTEOVATIONEX 3CC Formula May Not Set Properly After Shelf-Life.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65565-osteomed-osteovationex-3cc-formula-may-not-set-properly-after-shelf. Based on FDA recall #Z-2181-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2181-2020%22&limit=1).
The FDA announced on April 2, 2020, that Osteomed, LLC voluntarily recalled OSTEOVATIONEX 3CC INJECT FORMULA bone void filler kits due to an incorrect shelf-life label. The hazard is that the product may not maintain its setting characteristics for the labeled duration.
How to tell if you have it
Brand: Osteomed
Product: OSTEOVATIONEX 3CC INJECT FORMULA
REF/UDI: 390-0003/00813845020016
Lot codes: 17100402, 1127942, 1130302, 1135740, 1142070, 1142943
The hazard
The recalled bone void filler kits have an incorrect shelf-life label. According to the FDA, the product may not maintain its setting characteristics for the labeled shelf-life duration.
Context
GovInfoNow's records show Osteomed, LLC has two other recalls on record since October 28, 2021. On May 31, 2023, the company recalled Profile 0 4mm AutoDrive Screws due to the risk of screws passing through plate holes. On October 28, 2021, Osteomed recalled its OsteoPower Power Console for electrical safety risks that resulted in patient shock. Other recent recalls of similar products include XTANT nanOss 3D Bone Graft Substitute (March 9, 2026), Cerapedics PearMatrix P-15 Bone Graft (December 29, 2025), and Howmedica Osteonics acetabular inserts (July 30, 2026).
How to tell if you have this one
Check the product label for lot numbers: 17100402, 1127942, 1130302, 1135740, 1142070, 1142943. The product is an injectable bone void filler used in healing.
Brand
Osteomed
Category
Medical device
FDA recall event · 12 products
All 12 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
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.
Recall number
Product, codes & lots
Quantity
Z-2180-2020
OSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.; LOT 1135741, 1130301, 1127941
70
Z-2181-2020
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.; LOT 17100402, 1127942, 1130302, 1135740, 1142070, 1142943
270
Z-2182-2020
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.; LOT 1128523, 1129958, 1135746, 1142073, 17071104, 17100404 and 1126669
647
Z-2183-2020
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.; LOT 17040525, 1127972, 17071105, 1129957, and 1135744.
417
Z-2184-2020
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.; LOT 1127160, 1127031, 1130303, 1138055, 1139832, and 1142076
436
Z-2185-2020
OSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.; LOT 1128788, 1133246, 1126985 and 1135313
300
Z-2186-2020
OSTEOVATIONEX 3CC IMPACTFORMULA. REF/UDI: 390-0203/00813845020030 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.; LOT 17102713, 1156491, 17051907, 1136327 and 1126984
153
Z-2187-2020
OSTEOVATION 3CC IMPACTFORMULA. REF/UDI: 390-2103/00813845020078 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.; LOT 17051908, 17060107, 1132179, 1133245, 1135308 and 1142208
409
Z-2188-2020
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.; LOT 17060509, 17102710, 17040533, 17051911, 1126986, 1128789, 1134232, 1136330, 1144043 and 1142210
1724
Z-2189-2020
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.; LOT 1125793, 1129602, 1132492, 1132347, 1134448, 1137064 and 1142080
278
Z-2190-2020
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.; LOT 17051914, 17060506, 1127991, 1128827, 1132180, 1132479, 1134902 and 1142212
995
Z-2191-2020
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.; LOT 1127902, 1129603, 1132560, 1134444, 1137073, 1141342 and 1142084
651
Based on the official FDA remedy
What to do — step by step
Check Product Lot Number
Look for lot numbers on the product label: 17100402, 1127942, 1130302, 1135740, 1142070, 1142943.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 45 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2181-2020 (April 2, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2181-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.