CLASS II Device recall · Reported 10 Jun 2020 · FDA Enforcement Report

Osteovationex 3cc Impactformula recalled by Osteomed

Osteomed is recalling Osteovationex 3cc Impactformula, distributed nationwide in the US. The recall was initiated on 2 Apr 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLOT 17102713, 1156491, 17051907, 1136327 and 1126984

Quantity recalled153

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2186-2020
FDA event ID: 85529
Recalling firm: Osteomed, Addison, TX
Classification: Class II
Status: Terminated
Recall initiated: 2 Apr 2020
FDA classified: 29 May 2020
Reported: 10 Jun 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

2 Apr 2020	Recall initiated by company
29 May 2020	Classified by FDA	+57 days
10 Jun 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland

Questions about this recall

Is Osteovationex 3cc Impactformula recalled?

Yes. Osteomed recalled Osteovationex 3cc Impactformula on 2 Apr 2020. The recall is Class II and its status is Terminated. Recall number Z-2186-2020.

Why was it recalled?

Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.

Which lots are affected?

LOT 17102713, 1156491, 17051907, 1136327 and 1126984

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Osteomed

All 15

Reported	Class	Recall	Company	Reason	Where
19 Jul 2023Device	CLASS II	REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx recalled	Osteomed	Sterility	Nationwide
19 Jul 2023Device	CLASS II	REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only recalled	Osteomed	Sterility	Nationwide
15 Dec 2021Device	CLASS II	OsteoPower Power Console: -OsteoMed OsteoPower Power Console recalled	Osteomed	Other	Nationwide
10 Jun 2020Device	CLASS II	Osteovationex 5cc Impactformula recalled by Osteomed	Osteomed	Device Malfunction	Nationwide
10 Jun 2020Device	CLASS II	Osteovation 3cc Impactformula recalled by Osteomed	Osteomed	Device Malfunction	Nationwide

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