Biomet Recalls HipLOC Hip Fracture Fixation System Plates
Biomet UK Ltd. is recalling specific HipLOC hip fracture fixation system plates due to an undersized bore that prevents the lag screw from fitting.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving structural defects in medical devices are assigned a severity score of 4 (Severe).
Plain-English summary
Biomet UK Ltd. is recalling the HipLOC Hip Fracture Fixation System, specifically the Hiploc System 130 Plate 38 mm Barrel 4 Hole Plate (Item Number: 2110-130-004). The recall affects 1 unit from Lot Number 3222008. The product is indicated for the fixation of bone fractures, including intracapsular, intertrochanteric, and subtrochanteric fractures of the proximal femur.
The recall is being issued because the plate barrel has an undersized bore. This defect can result in the lag screw not fitting through the barrel. The agency has classified this as a Class II recall.
The affected product was distributed in the United States in the states of Arizona, Missouri, New Jersey, and New Mexico. Healthcare providers and patients should contact Biomet UK Ltd. for further instructions regarding the return or replacement of the affected device.
The recalled product
- Product
- HipLOC Hip Fracture Fixation System- Hiploc System 130¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-130-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal…
- Manufacturer
- Biomet UK Ltd.
- Affected units
- 1
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)
- Lot Number: 3222008
Distribution
Part of a larger recall action
This product is one of 4 recalled by Biomet UK Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Biomet UK Ltd.
See all →- HighBiomet Recalls HipLOC Hip Fracture Fixation System Plates Due to Fit Issues
FDA (Devices) · 2018-10-03
- HighBiomet Recalls HipLOC Hip Fracture Fixation System Plates
FDA (Devices) · 2018-10-03
- HighBiomet Recalls HipLOC Hip Fracture Fixation System Plates
FDA (Devices) · 2018-10-03
Same hazard · structural defect
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