CLASS III Device recall · Reported 18 May 2022 · FDA Enforcement Report

putty i-Factor Peptide Enhanced Bone Graft 1.0cc Syringe recalled

Cerapedics is recalling putty i-Factor Peptide Enhanced Bone Graft 1.0cc Syringe, distributed nationwide in the US. The recall was initiated on 14 Apr 2022 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesModel/Catalog Number: 700-010 UDI Code: (01)00850001680004(17)240531(10)21C0991 Lot Number: 21C0991

Quantity recalled572 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-1056-2022
FDA event ID: 90015
Recalling firm: Cerapedics, Westminster, CO
Classification: Class III
Status: Terminated
Recall initiated: 14 Apr 2022
FDA classified: 10 May 2022
Reported: 18 May 2022
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Syringes & Needles

Timeline

14 Apr 2022	Recall initiated by company
10 May 2022	Classified by FDA	+26 days
18 May 2022	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

Patient chart label contains incorrect Part Number and volume amount.

Product as listed by the FDA

putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY

Where it was distributed

U.S. Nationwide distribution in the states of AL, AZ, CA, CT, DC, DE, ID, IN, KS, KY, MD, MI, MN, MO, NC, NV, NY, OH, PA, TX, VA, and WA.

Nationwide Alabama Arizona California Connecticut District of Columbia Delaware Idaho Indiana Kansas Kentucky Maryland Michigan Minnesota Missouri North Carolina Nevada New York Ohio Pennsylvania Texas

Questions about this recall

Why was it recalled?

Patient chart label contains incorrect Part Number and volume amount.

Which lots are affected?

Model/Catalog Number: 700-010 UDI Code: (01)00850001680004(17)240531(10)21C0991 Lot Number: 21C0991

Where was it sold?

U.S. Nationwide distribution in the states of AL, AZ, CA, CT, DC, DE, ID, IN, KS, KY, MD, MI, MN, MO, NC, NV, NY, OH, PA, TX, VA, and WA.

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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Reported	Class	Recall	Company	Reason	Where
4 Feb 2026Device	CLASS II	PearMatrix P-15 Peptide Enhanced Bone Graft Bone Graft, 1.0cc recalled	Cerapedics	Other	Nationwide

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