Interpore Cross International Inc
Irvine, CA
Interpore Cross International Inc appears in FDA device records in Irvine, CA. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 5 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 5
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0619-2008 | Allogenix; DBM in a Lipid Carrier with Calcium Granules; Model Numbers: 02-3110, Interpore Cross International, a Biomet company (Allogenix DBM products contain human tissue (allograft bone) and are intended for transplantation) | Unapproved Testing: Interpore Cross International was recently informed that one of its human tissue suppliers, LifeLink Tissue Bank ("LifeLink"), utilized unapproved diagnostic testing (HBsAg & HBc) on certain lots of distributed donor tissue instead of the FDA approved screening test. As a result, Interpore Cross International has initiated a recall on specific lots of products containing human | Terminated | ||
| Z-0618-2008 | InterGro PLUS; DBM in a Lipid Carrier with Calcium Granules; Model Numbers: DBM002, DBM005, DBM010, DBMW05 & DBMW10, Interpore Cross International, a Biomet company (lnterGro DBM products contain human tissue (allograft bone) and are intended for transplantation) | Unapproved Testing:Interpore Cross International was recently informed that one of its human tissue suppliers, LifeLink Tissue Bank ("LifeLink"), utilized unapproved diagnostic testing (HBsAg & HBc) on certain lots of distributed donor tissue instead of the FDA approved screening test. As a result, Interpore Cross International has initiated a recall on specific lots of products containing human | Terminated | ||
| Z-0530-05 | Spinal Implant, Catalog number: 1000-3000 through 1000-3015 (9 catalog numbers) | Mislabeled. | Terminated | ||
| Z-0211-04 | C-Tek Anterior Cervical Plate System: 2.3mm/4.0mm Step Drill-14mm & 2.3mm/4.0mm Step Drill-16mm | Step drills from Lot 25947 may have been mis-etched. | Terminated | ||
| Z-0659-03 | TPS-TL Straight Drill Guide Applicator, Catalog Number 1300-9016. | Instrument fell apart during cleaning prior to surgery. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain