Synthes Spine: In Situ Bender Cutter Kit Narrow Sterile, Catalog number 530.522S. 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.

Recall number

Z-1641-2009

Recalling firm

Synthes Spine

Product

In Situ Bender Cutter Kit Narrow Sterile, Catalog number 530.522S. 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.

Status

Terminated

Initiated

2009-04-03

Posted

2009-05-21

Terminated

2010-09-15

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 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.

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.

Lot, serial or model codes

Lot numbers: TM00051 exp 9/24/02, TM00072 exp 03, TM00098 exp 1/31/05, TM00151 exp 10/31/05, TM00156 exp 3/9/07, TM00161 exp 12/29/07, TM00173 exp 3/30/08, TM00192 exp 5/30/08, TM00340 exp 1/3/11, TM00261 exp 3/10/09, TM00280 exp 7/31/09, TM00300 exp 10/10/09, TM00316 exp 2/27/10, TM00324 exp 4/8/10, and 4691525 exp 1/31/05.

510(k) numbers

["K021458"]

PMA numbers

not on file

Product code

HRS

Firm FEI

3005180112

Firm city

West Chester

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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