TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA device recall Z-1600-2015 · posted 2015-05-12 · Terminated
Recall details
- Recalling firm
- Synthes, Inc.
- Reason for recall
- TFNA nails from certain lots were assembled with a locking mechanism too close to the top of the nail. Potential patient impact: surgical delay.
- Action taken
- An urgent Field Safety Notification, dated April 9, 2015, was sent to end users and sales consultants to alert them about the issue and request that they take the following actions: 1) review the instructions listed in this notification; 2) forward this notice to anyone in your facility that needs to be informed; and 3) complete the attached Verification Section (page 4 of this notification) and send a copy of the completed Verification Section by: Fax: (888) 446-5160 or Scan/email: Synthes3152@stericycle.com.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 8175
- Distribution
- Distribution US Nationwide and Switzerland.
- Date initiated
- 2015-04-09
- Date posted
- 2015-05-12
- Date terminated
- 2016-08-18
- Location
- West Chester, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM (K131548) | Synthes (USA) Products, LLC | 2014-02-28 |