10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable
FDA device recall Z-0219-2015 · posted 2014-11-14 · Terminated
Recall details
- Recalling firm
- Synthes, Inc.
- Reason for recall
- The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assembled incorrectly. If the non conformance goes undetected, it may impact the locking function post-operatively and compromise the bone reduction and construct stability which may lead to non-union/malunion.
- Action taken
- An urgent medical device recall notice, dated October 29, 2014, was sent to end users that identified the product, problem and action to be taken. Customers were instructed to return the device to Synthes along with completing the verification section of the notice.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 6
- Distribution
- US Distribution in the states of: AK, FL, OH, OK, and TX.
- Date initiated
- 2014-10-29
- Date posted
- 2014-11-14
- Date terminated
- 2015-12-18
- Location
- West Chester, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM (K011857) | Synthes (Usa) | 2001-09-12 |