RTI Surgical Recalls OPTEFORM Allograft Paste Due to Incorrect Dispenser
RTI Surgical, Inc. is recalling 14 units of OPTEFORM Allograft Paste 5cc because they may contain a 10cc fluid dispenser with incorrect fill lines.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a packaging component (dispenser) with incorrect reference lines, which is a labeling/packaging issue rather than a direct contamination or structural defect causing immediate harm.
Plain-English summary
RTI Surgical, Inc. of Alachua, Florida, is recalling 14 units of OPTEFORM Allograft Paste, 5cc. The product is a bone void filler used in dental and orthopedic applications and is distributed by EXACTECH in Gainesville, Florida.
The recall was initiated because the recalled units may contain a 10cc fluid dispenser. This specific dispenser does not include the correct fluid fill line reference required for the reconstitution of 5cc paste allografts. The affected units were distributed to Florida and are identified by serial numbers 8504395 through 8504459 (excluding 8504451).
Healthcare providers and patients should stop using the affected units and contact RTI Surgical, Inc. or their distributor for further instructions.
The recalled product
- Product
- ***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic applications.***STERILE Using Radiation. ***Rx Only***Distributor: EXACTECH 2320 NW 66th Court, Gainesville, FL 32653 USA***Manufacturer: RTI Biologicals, Inc. 11621 Resea
- Manufacturer
- RTI Surgical, Inc.
- Affected units
- 14
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- Serial Numbers: 8504395
- 8504396
- 8504397
- 8504398
- 8504399
- 8504450
- 8504452
- 8504453
- 8504454
- 8504455
- 8504456
- 8504457
- 8504458 and 8504459.
Distribution
Distributed in 1 state:
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