Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0939-2014·Announced 2014-02-19

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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…
Manufacturer: RTI Surgical, Inc.
Category: Medical Device — Bone Graft / Allograft
Hazard: mis-labeling
packaging-defect
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:

Same manufacturer · RTI Surgical, Inc.

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Same hazard · mis labeling