CLASS II Device recall · Reported 23 Mar 2016 · FDA Enforcement Report
NuOss XC Sinus Reference No 509-3001 (BMCU17 recalled by Collagen Matrix
Collagen Matrix is recalling NuOss XC Sinus Reference No 509-3001 (BMCU17, size diameter height) Reference No 509-3002, distributed in Massachusetts. The recall was initiated on 13 May 2013 and the FDA has classified it as Class II.
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-1097-2016
- FDA event ID
- 73206
- Recalling firm
- Collagen Matrix, Franklin Lakes, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 May 2013
- FDA classified
- 11 Mar 2016
- Reported
- 23 Mar 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- E. coli
- Device type
- Surgical Instruments
Timeline
| 13 May 2013 | Recall initiated by company | |
| 11 Mar 2016 | Classified by FDA | +1033 days |
| 23 Mar 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
During the 36 month real time shelf life testing of NuOss XC Sinus (BMCU-Umbrella) to verify the 3 year shelf life designated for the device, 3 of 13 products did not pass the recovery test, which requires that the compressed product fully expand within 1 minute of hydration time.
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
NuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height) Reference No 509-3002 (BMCU22, size 22 mm diameter x 12 m height) Manufacturer:- Collagen Matrix, Distributor:- ACE Surgical Supply Co, Inc, Intended use for dental surgery such as -augmentation or reconstructive treatment of alveoloar ridge -filling of infrabony periodontal defects -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 intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) -Filling of pre-implant defects in conjunction with products intended for Guided Bone Regeneration
Where it was distributed
US Distribution to state of: MA.
Questions about this recall
Is NuOss XC Sinus Reference No 509-3001 (BMCU17, size diameter height) Reference No 509-3002 recalled?
Yes. Collagen Matrix recalled NuOss XC Sinus Reference No 509-3001 (BMCU17, size diameter height) Reference No 509-3002 on 13 May 2013. The recall is Class II and its status is Terminated. Recall number Z-1097-2016.
Why was it recalled?
During the 36 month real time shelf life testing of NuOss XC Sinus (BMCU-Umbrella) to verify the 3 year shelf life designated for the device, 3 of 13 products did not pass the recovery test, which requires that the compressed product fully expand within 1 minute of hydration time.
Which lots are affected?
Lot BMCXU11P1. BMCXU11H3 Lot BMCXU11P1, BMCXU12P1
Where was it sold?
US Distribution to state of: MA.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 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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