CLASS II Device recall · Reported 9 Jun 2021 · FDA Enforcement Report

OsteoFlex Cement and Mixing System recalled by Zavation

Zavation is recalling OsteoFlex Cement and Mixing System, distributed nationwide in the US. The recall was initiated on 25 Mar 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: 13844ZV, 12320ZV, 14359ZV, 14171ZV, 13887ZV, 12670ZV, 11759ZV, 11850ZV, 13750ZV, 14273ZV, 14017ZV, 13665ZV, 12766ZV, 12037ZV, 14100ZV, 11693ZV, 14472ZV, 14388ZV, 13651ZV, 13876ZV

Quantity recalled846 units

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-1768-2021
FDA event ID: 87661
Recalling firm: Zavation, Flowood, MS
Classification: Class II
Status: Terminated
Recall initiated: 25 Mar 2021
FDA classified: 1 Jun 2021
Reported: 9 Jun 2021
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Device type: Hip & Knee Implants

Timeline

25 Mar 2021	Recall initiated by company
1 Jun 2021	Classified by FDA	+68 days
9 Jun 2021	Published in enforcement report	+8 days

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

Reason for recall

Products distributed as sterile may not have been adequately sterilized

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

OsteoFlex Cement and Mixing System, REF VCF-OSFL. For use in Orthopedic / spinal procedures.

Where it was distributed

US nationwide distribution.

Nationwide

Stores named: Walmart

Questions about this recall

Is OsteoFlex Cement and Mixing System recalled?

Yes. Zavation recalled OsteoFlex Cement and Mixing System on 25 Mar 2021. The recall is Class II and its status is Terminated. Recall number Z-1768-2021.

Why was it recalled?

Products distributed as sterile may not have been adequately sterilized

Which lots are affected?

Lot Numbers: 13844ZV, 12320ZV, 14359ZV, 14171ZV, 13887ZV, 12670ZV, 11759ZV, 11850ZV, 13750ZV, 14273ZV, 14017ZV, 13665ZV, 12766ZV, 12037ZV, 14100ZV, 11693ZV, 14472ZV, 14388ZV, 13651ZV, 13876ZV

Where was it sold?

US nationwide distribution.

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 Zavation

All 71

Reported	Class	Recall	Company	Reason	Where
9 Jun 2021Device	CLASS II	ZVplasty Biopsy Device recalled by Zavation	Zavation	Sterility	Nationwide
9 Jun 2021Device	CLASS II	ZVplasty, Direct Bipedicular, Bone Access Kit with Coxaial Cannula recalled	Zavation	Sterility	Nationwide
9 Jun 2021Device	CLASS II	ZVplasty Cement Delivery Cannula recalled by Zavation	Zavation	Sterility	Nationwide
9 Jun 2021Device	CLASS II	Cemix - Cement Mixing System Sterile recalled by Zavation	Zavation	Sterility	Nationwide
9 Jun 2021Device	CLASS II	Beveled Trocar/cannula recalled by Zavation	Zavation	Sterility	Nationwide

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