Z-1165-2026Class II

PearMatrix P-15 Peptide Enhanced Bone Graft Bone Graft, 1.0cc REF: 730-010

Name: Z-1165-2026 PearMatrix P-15 Peptide Enhanced Bone Graft Bone Graft, 1.0cc REF: 730-010
Creator: Cerapedics, Inc.
Published: 2025-12-29
License: https://open.fda.gov/license/

Cerapedics, Inc. / initiated 2025-12-29 / Open, Classified / root cause: labeling and UDI

FDA source

Cerapedics, Inc. began a recall of PearMatrix P-15 Peptide Enhanced Bone Graft Bone Graft, 1.0cc REF: 730-010 on 2025-12-29. FDA classified it as Class II and gives the reason as "Incorrect expiration date". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1165-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-29
Posted: 2026-01-23
Recalling firm: Cerapedics, Inc.
Product: PearMatrix P-15 Peptide Enhanced Bone Graft Bone Graft, 1.0cc REF: 730-010
Product code: NOX Filler, Bone Void, Synthetic Peptide
Reason for recall: Incorrect expiration date
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On December 29, 2025, Cerapedics issues a "Urgent: Medical Device Recall" notification to affected consignees via Email. Cerapedics asked consignees to take the following actions: 1. Please immediately examine your inventory and return any remaining units of PearlMatrix 1.0cc, lot 7014819. " RMA will be issued for this return and a shipping label. 2. Please acknowledge receipt of this letter by responding to this email or call toll-free at 1-866-360-5612. 3. If you have further distributed this product, please identify your customers, and notify them at once of this product recall. You may provide a copy of this recall notification letter to your customer.
Quantity in commerce: 237 units
Distribution: US Nationwide distribution in the states of CA, CO, CT, FL, GA, ID, IL, KS, LA, MI, MN, MO, MT, NE, NJ, NV, NY, OH,OR, PA, TN, TX, WA, WY.
Product codes and lots: Lot: 7014819/UDI: (01)00850001680196

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1165-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1165-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-23

Product code NOX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)