Reported May 7, 2014 · Terminated
The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS…
Acumed LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Acumed LLC · 5885 NW Cornelius Pass Rd · Hillsboro, OR · 97124-9432
Is this the product you have?
5 of 5 products
| Model / number | Product as published |
|---|---|
| — | The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS Cable/Sleeve |
01-0020-S | 2.0 mm SS Sleeve Only |
01-0022-S | 8, 7 hole, SS compression plate |
02-2007-S | 10, 9 hole, SS compression plate |
02-2009-S | Product Usage: The Osteo-Clage Stainless Steel Bone Plate is an implantable straight, rigid stainless steel plate. It is 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 |
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 Lot # 222078, 232175, 245032, 254368, 261903, 270659, 284155, 297281. 2.0mm SS sleeve only 2 Lot # 247553, 267469, 280871, 313261. 8, 7 hole SS compression plate 3 Lot # 300381. 10, 9 hole SS compression plate 4 Lot # 299641. - Amount recalled
- 141 units in the US; 294 units outside the US.
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Manufacturing of these devices with a grade of stainless steel that is not within specifications.
This product could cause temporary or reversible health problems — stop using it.
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