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U.S. Department of Health and Human Services

Class 2 Device Recall PearlMatrix" P15 Peptide Enhanced Bone Graft

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 Class 2 Device Recall PearlMatrix" P15 Peptide Enhanced Bone Graftsee related information
Date Initiated by FirmDecember 29, 2025
Date PostedJanuary 23, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1165-2026
Recall Event ID 98242
PMA NumberP240001 
Product Classification Filler, bone void, synthetic peptide - Product Code NOX
ProductPearMatrix P-15 Peptide Enhanced Bone Graft Bone Graft, 1.0cc REF: 730-010
Code Information Lot: 7014819/UDI: (01)00850001680196
Recalling Firm/
Manufacturer		 Cerapedics, Inc.
11025 Dover St Unit 1600
Westminster CO 80021-5574
For Additional Information ContactRebecca Helpert
510-333-1697
Manufacturer Reason
for Recall		Incorrect expiration date
FDA Determined
Cause 2		Labeling Change Control
ActionOn 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 Commerce237 units
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = NOX
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