Acumed Recalls 6-Hole Pubic Symphysis Plates Due to Material Error
Acumed LLC is recalling 15 units of 6-hole Pubic Symphysis plates because they were manufactured with the wrong titanium alloy.
What this means for you
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 with a material specification error (wrong alloy) where no injuries or illnesses have been reported, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Acumed LLC is recalling 15 units of the 6-hole Pubic Symphysis plate (PN 70-0451), lot number 383813. These pelvic bone plates are internal fixation devices used by surgeons for fractures, fusions, and osteotomies of the pelvic ring.
The recall was initiated because the recalled batch was manufactured using Titanium Alloy (Ti-6Al-4V ELI per ASTM F135) instead of the specified Commercially Pure Titanium (ASTM F67 - CP Grade 4). The source text does not report any illnesses, injuries, or adverse events associated with this material discrepancy.
The affected units were distributed worldwide to Costa Rica, Malaysia, Mexico, South Africa, and Spain. Healthcare facilities and patients who have received these specific plates should contact Acumed LLC for instructions on removal or replacement.
The recalled product
- Product
- 6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are a series of plates with varying lengths that function as internal fixation devices for fractures, fusions and osteotomies of the pelvic ring. The plates are strategically pre-contoured wher
- Manufacturer
- Acumed LLC
- Affected units
- 15
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: 383813
Distribution
Distribution scope not specified by the agency.
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