Biomet Optigun Ratchet Cement Gun Recalled Due to Pin Disconnection Risk
Biomet France is recalling three Optigun Ratchet cement guns because a pin may disconnect and be lost, potentially delaying surgery or requiring revision.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that may necessitate revision surgery if the pin falls into the surgical site, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Biomet France S.A.R.L. is recalling three units of the Optigun Ratchet, a hand-held cement gun used to deliver bone cement from the Optivac system. The recall is due to a defect where the pin that maintains the knob button may disconnect and become lost.
The distribution of these devices was nationwide to medical doctors only. The specific units affected are identified by catalog number 419500 and lot number 0101296012.
If the pin disconnects, it may result in a delay of surgery while a new Optigun is obtained and the pin is detected or retrieved. If the pin falls into the surgical site and is not detected, it may necessitate revision surgery.
The recalled product
- Product
- The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver bone cement from the Optivac.
- Manufacturer
- BIOMET FRANCE S.A.R.L.
- Affected units
- 3
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 (1)
- Catalog number: 419500 Lot number: 0101296012
Distribution
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