Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part
FDA device recall Z-1352-2015 · posted 2015-03-30 · Terminated
Recall details
- Recalling firm
- Synthes, Inc.
- Reason for recall
- The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments.
- Action taken
- DePuy Synthes sent an Urgent Notice: Medical Device Recall letter, dated March 2, 2015, to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to review inventory for the affected parts and following the actions provided in the letter for removal and replacement of these devices. For questions call 610-719-5450.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 131
- Distribution
- US Nationwide Distribution - NY, TX, MD, OR, MS, ND, CA, AZ, MI, IL, PA, TN, AR, SD, SC, FL, VA, OK, and GA
- Date initiated
- 2015-02-24
- Date posted
- 2015-03-30
- Date terminated
- 2015-09-21
- Location
- West Chester, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM (K131548) | Synthes (USA) Products, LLC | 2014-02-28 |