CLASS III Device recall · Reported 23 Mar 2016 · FDA Enforcement Report
Zcore Porcine Xenograft Particulate recalled by Collagen Matrix
Collagen Matrix is recalling Zcore Porcine Xenograft Particulate in Syringe Product Intended for use in dental surgery, distributed in Texas. The recall was initiated on 17 Nov 2015 and the FDA has classified it as Class III.
Check your package
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-1173-2016
- FDA event ID
- 73208
- Recalling firm
- Collagen Matrix, Franklin Lakes, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 17 Nov 2015
- FDA classified
- 14 Mar 2016
- Reported
- 23 Mar 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- E. coli
- Device type
- Syringes & Needles
Timeline
| 17 Nov 2015 | Recall initiated by company | |
| 14 Mar 2016 | Classified by FDA | +118 days |
| 23 Mar 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The distributor, Osteogenics Biomedical, notified the firm that the syringes were not working properly and the syringes were being held in quarantine.
Some strains of E. coli, such as O157:H7, produce a toxin that can cause severe stomach cramps, bloody diarrhea and, in a small number of cases, kidney failure.
Product as listed by the FDA
ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in dental surgery such as: -Augmentation or reconstructive treatment of alveolar ridge -filling of defects after root resection, apicoectomy and cystectomy -Filling of extraction sockets to enhance preservation of the alveolar ridge -elevation of maxillary sinus floor -Filling of periodontal defects in conjunction with products -Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) -Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration.
Where it was distributed
US in the state of TX
Questions about this recall
Why was it recalled?
The distributor, Osteogenics Biomedical, notified the firm that the syringes were not working properly and the syringes were being held in quarantine.
Which lots are affected?
PMCS025 Lot No. PMCSU15A1 PMCS05 Lot No. PMCSU15A1 PMCS10 Lot No. PMCSU15A1 PMCS05 Lot No. PMCSU15A2 PMCS10 Lot No. PMCSU15A2
Where was it sold?
US in the state of TX
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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