Z-0344-2013Class II

IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service...

Name: Z-0344-2013 IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service...
Creator: Extremity Medical LLC
Published: 2011-04-13
License: https://open.fda.gov/license/

Extremity Medical, LLC / initiated 2011-04-13 / Terminated / root cause: manufacturing process

FDA source

Extremity Medical LLC began a recall of IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079. The Extremity Medical Screw and Washer System... on 2011-04-13. FDA classified it as Class II and gives the reason as "Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0344-2013
Classification: Class II
Status: Terminated
Initiated: 2011-04-13
Posted: 2012-11-18
Terminated: 2013-03-21
Recalling firm: Extremity Medical, LLC
Product: IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079. The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand and wrist.
Product code: HWC Screw, Fixation, Bone
Reason for recall: Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Extremity Medical sent an e-mail notification (Extremity Medical- Sales Bulletin- IO Fix) dated April 13, 2011 to distributors notifying them of a change made to the 4.0 mm Lag Screw.
Quantity in commerce: 120 Units
Distribution: Worldwide Distribution-USA (nationwide) including the states FL, MA, NC, CA, MD, VA, IN, AL, NJ, AZ, OK, MT, NY, OH, IA, MI, TX, WI, GA, IL, TN and NE, and the country of Switzerland.
Product codes and lots: Product coding is listed as Catalog Number: Lot Number and are as follows: 118-30014:107509; 118-30016:107510; 118-30018:107511; 118-30020:107512; 118-30020:107513; 118-30022:107514; 118-30024:107515; 118-30026:107516; 118-40020:107457; 118-40025:107458; 118-40030;107529; 118-40030;107459; 118-40035:107460; 118-40040:107461; 118-40045:107462; 118-40050:107463; 118-40320:107613; 118-40325:107614; 118-40330:107615; 118-40330:107616; 118-40335:107617; 118-40340:107618; 118-40345:107619; 118-40350:107620.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0344-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0344-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-17

Product code HWC

K101700Class IIIo Fix Hand, Io Fix Foot, Extremity Medical Screw SystemExtremity Medical, LLC / cleared 2010-10-12

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)