Z-0235-2016 Class II Terminated
FDA device recall Z-0235-2016 was initiated by Stryker Sustainability Solutions on Oct 14, 2015 and is designated Class II. Reason for recall: It was reported that packaging was not properly sealed. The recall status is terminated (terminated May 6, 2016). Affected quantity: 1202.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 18, 2015
- Initiation Date
- Oct 14, 2015
- Termination Date
- May 6, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1202
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.
Distribution Pattern
US ( nationwide) Distribution to the states of : MN, OH, CA, IN, WI, FL, GA, MO, IA, MT, LA, KS, TX, TN, WY, MD, NJ, WA, PA, SC, NY, MI, AT, HI, MN, AR, AZ, IL, IA, KY, MS, UT, NC, VA, CO, ME and ID., Internationally to Canada.
Code Information
Item No/Model No: 2108-109, 4125-127-090, 2108-110, 2108-115, 2108-120, 2108-151-001, 2108-152, 2108-158, 2108-182, 2108-218, 310.25, 4118-127-090, 4125-147-090, 4806-110-25, 5071-553, 6118-127-90, 6125-127-090 Lot Code: 3743743, 3750611, 3750630, 3753894, 3761982, 3775827, 3779058, 3779129, 3782549, 3782554, 3782565, 3785624, 3785630, 3785676, 3789092, 3789102, 3794000, 3794085, 3796706, 3796799, 3799827, 3802103
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0235-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026