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i-FACTOR Peptide Enhanced Bone Graft recallZ-1056-2022 · Cerapedics, Inc. · initiated Apr 14, 2022

Class III Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Cerapedics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Patient chart label contains incorrect Part Number and volume amount.

FDA root cause category: Under Investigation by firm

What the company is doing

On 04/14/2022, Cerapedics, Inc. email a "Medical Device Recall" letter to customer informing them that the firm is voluntarily recalling all units of i-FACTOR 1.0cc Putty from lot 21C0991 due to the incorrect product code on the patient chart label. Customers are asked to: 1) Examine their inventory and return any remaining units from lot 21C0991 using the provided RMA number. 2) Respond to the Recall email or call toll free at 1-866-360-5612 to report the number of units at their location. 3) If the affected product has been further distributed, notify those customers of the recall utilizing the recall notification letter. Questions or assistance - contact Customer Service at 1-866-360-5612.

Recall details

Recall number
Z-1056-2022
Recall class
Class III
Status
Terminated
Initiated by the company
Apr 14, 2022
Recalling firm
Cerapedics, Inc.
Quantity
572 units
Product code
NOX
FDA submissions
P140019
Distribution
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.

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

3 devices cleared under P140019 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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