Recall Z-0765-2017— Stryker Sustainability Solutions
Class II · Terminated
Class II FDA medical device recall by Stryker Sustainability Solutions, initiated 2016-11-11, terminated 2017-05-05. It names one FDA 510(k) clearance: K062497. Product: Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.. Reason: An increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in the packaging or during use..
- Recalling firm
- Stryker Sustainability Solutions
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-11-11
- Terminated
- 2017-05-05
- Firm location
- Tempe, AZ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.
Reason for recall
An increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in the packaging or during use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.