Biomet Recalls Shortened Plug Driver Due to Instrument Tip Shearing
Biomet is recalling two units of a Shortened Plug Driver after a complaint reported the instrument tip sheared off during a surgical removal case.
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 is classified as FDA Class II, and the source describes a mechanical failure (tip shearing) during a surgical procedure, which poses a risk of harm to the patient, although no specific injuries or illnesses are reported in the text.
Plain-English summary
Biomet is recalling two units of the Shortened Plug Driver, a non-sterile, prescription-only medical device used in spinal fixation procedures. The recall is limited to Lot #184090, Catalog # LV00407, and Device Listing # D090878. The device was distributed to California.
The recall was initiated following a complaint received on May 20, 2013, which reported that the tip of the instrument sheared off during a removal case. The Shortened Plug Driver is part of the Polaris Spinal Systems, intended for immobilization and stabilization as an adjunct to fusion in non-cervical spinal fixation.
Healthcare providers and patients who have used or possess this specific device should contact Biomet for further instructions. The device is intended for use by trained medical professionals in a clinical setting.
The recalled product
- Product
- Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The Polaris Spinal Systems is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedical screw…
- Manufacturer
- Ebi, Llc
- Affected units
- 2
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)
- Device listing # D090878 Catalog # LV00407 Lot #184090
Distribution
Distributed in 1 state:
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