Recall Z-1983-2014 ยท HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
The Anspach Effort, Inc.
Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and cranium.
| Date | Jul 3, 2014 (initiated May 8, 2014) |
| Status | Terminated |
| Reason | Several attachments and handpieces failed to meet the expected sterility assurance level (SAL) when sterilized by the method that is specified in the current Directions for Use (DFU) provided with the device. |
| Root cause | Process control |
| Action | Customers were notified 05/08/2014 by a Return Receipt Requested letter from Anspach with an URGENT: Medical Device Labeling Correction announcement, REGARDING: STERRAD 100S Hydrogen Peroxide Gas Plasma Technology no longer recommended for sterilization of Anspach products. The letter identified the problem and actions to be taken by the customer. Customers were to complete and return the attached reply form. If the products were distributed further, then those customers should have been notified as well. Customers were to contact Anspach Customer Support at 1-800-327-6887 if they want cop |
| Quantity | 115,988 units |
| Distribution | Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX,UT, VA, VT, WA, WI, WV, WY, and Hawaii, and the territories of Puerto Rico, U |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955084 | ASPACH 65,000 (MODIFICATION) The Anspach Effort, Inc., Jan 17, 1996 |