Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0939-2014 — REF 606-01-05OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic applications.STERILE Using Radiation. Rx OnlyDistributor: EXACTECH 2320 NW 66th Court, Gainesville, FL 32653 USAManufacturer: RTI Biologicals, Inc. 11621 Research Circle, Alachua,

U.S. FDA — Device Enforcement · United States · 2013-12-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0939-2014
Date of alert: 2013-12-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: RTI Surgical, Inc.
Product category: device
Product type: Devices

Reported risk: RTI Surgical, Inc. of Alachua, FL is recalling their OPTEFORM Allograft Paste, 5cc as it may contain a 10 cc fluid dispenser. The 10cc fluid dispenser does not include the correct fluid fill line reference for reconstitution of 5cc past allografts.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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