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.
This recall has been terminated (originally issued May 21, 2009).
- Company
- Synthes Spine
- Recall Initiated
- April 3, 2009
- Posted
- May 21, 2009
- Terminated
- September 15, 2010
- Recall Number
- Z-1640-2009
- Quantity
- 2706 units total
- Firm Location
- West Chester, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Sterility may be compromised due to a ineffective package design.
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.
Lot / Code Info
Lot numbers TM00119 exp 6/30/05, TM00122 exp 7/31/04, TM00124 exp 7/31/04, TM00128 exp 9/30/05, TM00150 exp 10/31/06, TM00155 exp 3/9/07, TM00160 exp 12/29/08, TM00172 exp 3/30/09, TM00197 exp 7/31/09, TM00220 exp 9/7/09, TM00221 exp 9/7/09, TM00260 exp 3/10/10, TM00271 exp 4/28/10, TM00295 exp 10/10/10, TM00315 exp 2/28/11, TM00322 exp 4/13/11, 4859489 exp 7/30/05, 4859490 exp 6/30/05, 4859492 exp 7/31/05, and TM00341 exp 3/12/12.
Root Cause
Package design/selection
Action Taken
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 letter with the recalled product to the address provided. Customers that do not have the identified product, are to complete the attached form and return the document to the address provided acknowledging their receipt of the recall information. Questions should be directed to their Synthes CMF Sales Consultant.