Recall Z-0904-2018— Synthes (USA) Products LLC
Class II · Terminated
Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2017-07-26, terminated 2018-09-10. FDA's recall record names no specific 510(k) clearance for this event. Product: 3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351.76S Reaming Rods are intended for guiding of reamers during orthopedic surgery.. Reason: Possible lack of product sterility due to potential gaps/channeling in the seal of the package..
- Recalling firm
- Synthes (USA) Products LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-07-26
- Terminated
- 2018-09-10
- Firm location
- West Chester, PA, United States
Product description
3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351.76S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
Reason for recall
Possible lack of product sterility due to potential gaps/channeling in the seal of the package.
Data sourced from openFDA. This site is unofficial and independent of the FDA.