Extremity Medical Recalls IO Fix IntraOsseous Fixation System Due to Screw Failure
Extremity Medical LLC is recalling 120 units of the IO Fix IntraOsseous Fixation System because product event reports indicate lag screws may pass through washers during surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a mechanical failure of a medical device during surgery. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).
Plain-English summary
Extremity Medical LLC is recalling 120 units of the IO Fix IntraOsseous Fixation System. The recall was initiated after Product Event Reports revealed that lag screws can pass through washers (e.g., X-Post) intra-operatively. The affected product is intended for the 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.
The affected units were distributed nationwide in the United States and in Switzerland. Specific states identified in the distribution pattern include Florida, Massachusetts, North Carolina, California, Maryland, Virginia, Indiana, Alabama, New Jersey, Arizona, Oklahoma, Montana, New York, Ohio, Iowa, Michigan, Texas, Wisconsin, Georgia, Illinois, Tennessee, and Nebraska. The recall covers specific catalog and lot numbers, including 118-30014:107509, 118-30016:107510, and 118-30018:107511, among others.
Healthcare providers and facilities should stop using the affected products immediately. Extremity Medical LLC has provided customer service contact information at 888.499.0079 for further instructions regarding the recall and return of the devices.
The recalled product
- 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…
- Manufacturer
- Extremity Medical LLC
- Affected units
- 120
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
- 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
Distribution
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