CLASS II Device recall · Reported 7 May 2014 · FDA Enforcement Report
The Osteo-Clage System consists of stainless steel recalled by Acumed
Acumed is recalling The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates, distributed nationwide in the US. The recall was initiated on 26 Mar 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1515-2014
- FDA event ID
- 67885
- Recalling firm
- Acumed, Hillsboro, OR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Mar 2014
- FDA classified
- 25 Apr 2014
- Reported
- 7 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 26 Mar 2014 | Recall initiated by company | |
| 25 Apr 2014 | Classified by FDA | +30 days |
| 7 May 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Manufacturing of these devices with a grade of stainless steel that is not within specifications.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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 plate; Part Number 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
Where it was distributed
US Nationwide Distribution - in the states of CA, CO, FL, GA, LA, MI, MN, MO, OH, OR, PA, PR, TX, UT, VA, WA and WY. Product was distributed outside the US to: Australia, China, Figi, France, Great Britain, Italy, Japan, Korea, Maylasia, Sweden, South Africa, Spain.
Nationwide CaliforniaColoradoFloridaGeorgiaLouisianaMichiganMinnesotaMissouriOhioOregonPennsylvaniaPuerto RicoTexasUtahVirginiaWashingtonWyoming
Questions about this recall
Why was it recalled?
Manufacturing of these devices with a grade of stainless steel that is not within specifications.
Which lots are affected?
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.
Where was it sold?
US Nationwide Distribution - in the states of CA, CO, FL, GA, LA, MI, MN, MO, OH, OR, PA, PR, TX, UT, VA, WA and WY. Product was distributed outside the US to: Australia, China, Figi, France, Great Britain, Italy, Japan, Korea, Maylasia, Sweden, South Africa, Spain.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 67885| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Tension Band Pin is a fixation pin which is .0625" recalled by Acumed | Acumed | Foreign Material | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Hexalob Screw various sizes recalled by Acumed | Acumed | Device Malfunction | Nationwide |
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| Device | CLASS II | AcuTwist Acutrak Compression Screws recalled by Acumed | Acumed | Other | Nationwide |
| Device | CLASS II | Dual-Trak Clavicle Screws recalled by Acumed | Acumed | Other | Nationwide |
| Device | CLASS II | Cannulated Screw, Short Thread recalled by Acumed | Acumed | Foreign Material | Nationwide |
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