Recall Z-1515-2014 ยท HTY Pin, Fixation, Smooth
Acumed LLC
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 sta
| Date | Apr 25, 2014 (initiated Mar 26, 2014) |
| Status | Terminated |
| Reason | Manufacturing of these devices with a grade of stainless steel that is not within specifications. |
| 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 BusinessService@acumed.net or via phone at 877-627-9957. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964500 | ACUMED TENSION BAND PIN Acu Med, Inc., Dec 9, 1996 |