Recall Z-0235-2016— Stryker Sustainability Solutions
Class II · Terminated
Class II FDA medical device recall by Stryker Sustainability Solutions, initiated 2015-10-14, terminated 2016-05-06. FDA's recall record names no specific 510(k) clearance for this event. Product: SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades Surgical drill bits, blades, burs, chisels, rasps, taps and reamers are specially designed surgical accessories to help the surgeon cut and drill bone and bony structures. Reprocessed surgical accessories are indicated for use in patients requiring surgery involving bone and bony structures.. Reason: It was reported that packaging was not properly sealed..
- Recalling firm
- Stryker Sustainability Solutions
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-10-14
- Terminated
- 2016-05-06
- Firm location
- Tempe, AZ, United States
Product description
SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades Surgical drill bits, blades, burs, chisels, rasps, taps and reamers are specially designed surgical accessories to help the surgeon cut and drill bone and bony structures. Reprocessed surgical accessories are indicated for use in patients requiring surgery involving bone and bony structures.
Reason for recall
It was reported that packaging was not properly sealed.
Data sourced from openFDA. This site is unofficial and independent of the FDA.