Spetzler Claw Tip, Universal - 5450-800-311 Spetzler Open Angle Micro Claw Tip, Universal - 5450-800-313 The Spetzler Cl
FDA device recall Z-1378-2016 · posted 2016-04-13 · Terminated
Recall details
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Reason for recall
- The Spetzler Claw Tip was packaged with the incorrect Tip Sleeve Assembly. The Tip Sleeve Assembly included in the packaging is the incorrect size. Risk to Health: If the Tip Sleeve Assembly does not fit the Spetzler Claw" Tip, a surgical delay may occur while an alternate Tip Sleeve Assembly is retrieved.
- Action taken
- On 3/22/2016, URGENT MEDICAL DEVICE RECALL NOTIFICATION notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions regarding this recall, please contact Stryker Instruments: Kara Spath 269-389-4518 kara.spath@stryker.com
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- LFL
- Quantity affected
- 140 units
- Distribution
- Distributed in the states of AZ, CA, CO, CT, IL, IN, MD, MI, MN, NY, PA, SC, TN, WA, WI, and VA, and in the NETHERLANDS.
- Date initiated
- 2016-03-22
- Date posted
- 2016-04-13
- Date terminated
- 2016-07-19
- Location
- Portage, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE (K020220) | Synergetics, Inc. | 2002-08-23 |