Acumed Osteo-Clage System Recalled for Non-Specification Stainless Steel
Acumed LLC is recalling the Osteo-Clage System because the stainless steel used in manufacturing was not within specifications.
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 an implantable medical device with a material defect (stainless steel not within specifications). Per the rubric, this is classified as a risk-of-harm product where injury has not yet been reported, corresponding to a score of 3.
Plain-English summary
Acumed LLC is recalling the Osteo-Clage System, which consists of stainless steel cable/sleeves and compression plates. The recall is due to the manufacturing of these devices with a grade of stainless steel that is not within specifications.
The affected products include 2.0 mm x 850mm SS Cable/Sleeves, 2.0 mm SS Sleeves Only, 8/7 hole SS compression plates, and 10/9 hole SS compression plates. Specific lot numbers are listed in the structured product information. The Osteo-Clage Stainless Steel Bone Plate is an implantable straight, rigid stainless steel plate used in conjunction with 4.5mm Cortical bone screws to provide compression across bone fractures. The Osteo-Clage Cerclage Wire Crimp sleeve is used in conjunction with the bone plate in cerclage fixation procedures.
A total of 141 units were distributed in the US, and 294 units were distributed outside the US. US distribution included the states of CA, CO, FL, GA, LA, MI, MN, MO, OH, OR, PA, PR, TX, UT, VA, WA, and WY. International distribution included Australia, China, Fiji, France, Great Britain, Italy, Japan, Korea, Malaysia, Sweden, South Africa, and Spain.
The recalled product
- Product
- The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS Cable/Sleeve; Part Number 01-0020-S 2.0 mm SS Sleeve Only; Part Number 01-0022-S 8, 7 hole, SS compression plate; Part Number 02-2007-S 10, 9 hole, SS compression p
- Manufacturer
- Acumed LLC
- Hazard
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)
- 2.0mm x 80mm SS cable/sleeve: Lot # 222078
- 232175
- 245032
- 254368
- 261903
- 270659
- 284155
- 297281. 2.0mm SS sleeve only: Lot # 247553
- 267469
- 280871
- 313261. 8
- 7 hole SS compression plate: Lot # 300381. 10
- 9 hole SS compression plate: Lot # 299641.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Acumed LLC 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.
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