The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS Cable/Sleev
FDA device recall Z-1515-2014 · posted 2014-04-25 · Terminated
Recall details
- Recalling firm
- Acumed LLC
- Reason for recall
- Manufacturing of these devices with a grade of stainless steel that is not within specifications.
- Action taken
- 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.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- HTY
- Quantity affected
- 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 Br
- Date initiated
- 2014-03-26
- Date posted
- 2014-04-25
- Date terminated
- 2015-02-04
- Location
- Hillsboro, OR
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUMED TENSION BAND PIN (K964500) | Acu Med, Inc. | 1996-12-09 |