Recall Z-1640-2009 ยท HRS Plate, Fixation, Bone
Synthes Spine
In Situ Bender Cutter Kit Wide Sterile, Catalog number 530.521S Used with Synthes' Rapid Resorbable Fixation System which is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in adults and children.
| Date | May 21, 2009 (initiated Apr 3, 2009) |
| Status | Terminated |
| Reason | Sterility may be compromised due to a ineffective package design. |
| Root cause | Package design/selection |
| Action | All affected Synthes DMF Sales Consultants were notified of the Medical Device Recall by an Urgent: Medical Device Recall letter notification which was sent via USPS certified mail on 4/6/09. The letter stated the problem and risk. The firm recommended that patients who have had a surgical procedure in which these products were utilized be monitored for signs/symptoms of infection for a period of six months following surgery. If customers have any of the identified devices, they are to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number; complete the form; and return the |
| Quantity | 2706 units total |
| Distribution | Worldwide Distribution -- USA including states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, 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, and WV and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021458 | SYNTHES IN-SITU BENDER/CUTTER Synthes (Usa), Jul 24, 2002 |