Z-1515-2014Class II

The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS...

Name: Z-1515-2014 The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS...
Creator: Acumed LLC
Published: 2014-03-26
License: https://open.fda.gov/license/

Acumed LLC / initiated 2014-03-26 / Terminated / root cause: manufacturing process

FDA source

Acumed LLC began a recall of 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... on 2014-03-26. FDA classified it as Class II and gives the reason as "Manufacturing of these devices with a grade of stainless steel that is not within specifications". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1515-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-26
Posted: 2014-04-25
Terminated: 2015-02-04
Recalling firm: Acumed LLC
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 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
Product code: HTY Pin, Fixation, Smooth
Reason for recall: Manufacturing of these devices with a grade of stainless steel that is not within specifications.
Root cause tag: manufacturing process
FDA root cause: Component change control
Action: Acumed sent an Urgent Medical Device Recall letter dated March 26, 2014 to all affected customers. The letter identified the affected products, problem and actions to be taken. Customers are instructed to immediately stop using and/or distributing all lots identified in the letter. Return affected products as instructed in the letter. For questions contact Acumed Business Service via email at [email protected] or via phone at 877-627-9957.
Quantity in commerce: 141 units in the US; 294 units outside the US.
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1515-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1515-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-07	2014-04-25
Z-1516-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-07	2014-04-25

Product code HTY

K964500Class IIAcumed Tension Band PinAcu Med, Inc. / cleared 1996-12-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)