Recall Z-0903-2018 ยท HTO Reamer
Synthes (USA) Products LLC
2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
| Date | Jul 26, 2017 |
| Status | Terminated |
| Reason | Possible lack of product sterility due to potential gaps/channeling in the seal of the package. |
| Root cause | Process control |
| Action | The firm, DePuy Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated 7/26/2017 to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to do the following: If you DO have any of the identified devices and intend to re-sterilize the product (TRAUMA Products only) per the package insert, please take the following steps: Complete the Verification Section at the end of this letter by checking the appropriate box indicating affected product has been located and will be re-sterilized. Also, please indicate the number of de |
| Quantity | 1144 |
| Distribution | Worldwide Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, the District of Columbia, including Puerto R |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.