External Fixation Wire May Fracture During Surgery, Leaving Fragments in Patient
OrthoPediatrics Corp is recalling an external fixation wire due to manufacturing variance that may cause the tip to fracture. Fractured fragments could remain in patients.
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: FDA Class II recall with no reported illnesses or injuries. The hazard—potential wire tip fracture retained in the patient—is a risk-of-harm scenario where injury has not yet been reported, per rubric criterion for High severity.
Plain-English summary
OrthoPediatrics Corp has recalled 640 units of the Orthex External Fixation Wire Sharp Bayonet (1.8 x 400 mm, Model K400-18BN) due to a manufacturing defect. A variance near the transition zone of the wire tip increases the risk that the tip may fracture during use.
The affected wire is used in orthopedic external fixation procedures. The product was distributed nationwide in the United States (Arizona, Alabama, California, Florida, Maryland, Missouri, North Carolina, New York, and Texas) and internationally to Australia. Lot numbers 239006-B and 238997-B are affected.
If a fractured wire tip breaks off during surgery and remains in the patient, surgical teams may need to attempt retrieval, which could delay the procedure and potentially cause soft tissue damage or increase healing time. Patients or healthcare providers who have received or used this product should contact OrthoPediatrics Corp or their healthcare provider for guidance.
The recalled product
- Product
- Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
- Manufacturer
- OrthoPediatrics Corp
- Affected units
- 640
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 (1)
- UDI: 00841132179468 Lot Numbers: 239006-B and 238997-B
Distribution
Related recalls
Same manufacturer · OrthoPediatrics Corp
See all →- HighOrthopedic Implant Bolts Recalled Due to Breakage Risk in Bone Correction
FDA (Devices) · 2023-02-22
- SevereOrthoPediatrics Recalls Spine Rods Due to Potential Fracture Risk
FDA (Devices) · 2020-08-05
- ModerateOrthoPediatrics Recalls ShieldLoc ACL Implant Components Due to Labeling Errors
FDA (Devices) · 2020-07-15
- ModerateOrthoPediatrics Recalls ShieldLoc ACL Implant Components Due to Labeling Errors
FDA (Devices) · 2020-07-15
- ModerateOrthoPediatrics Recalls Adolescent Nail Attachment Bolts Due to Binding Risk
FDA (Devices) · 2019-11-06
Same hazard · tip fracture
See all →- HighSurgical anchor inserter recalled for potential tip fracture and bone damage
FDA (Devices) · 2023-06-14
Similar recalls
- SevereExactech Recalls Ergo 3.2mm K-wires Due to Fracture Risk
FDA (Devices) · 2019-10-30
- HighK-Wire Devices Recalled for Incorrect Length and Diameter Specifications
FDA (Devices) · 2022-05-11
- SevereZimmer Biomet Recalls ECT Internal Fixation Drill Bits Due to Fracture Risk
FDA (Devices) · 2017-10-04
- HighZimmer Biomet Recalls ECT Internal Fracture Fixation Drill Bits
FDA (Devices) · 2017-10-04
- SevereZimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk
FDA (Devices) · 2017-10-04
- HighOrthopedic Implant Bolts Recalled Due to Breakage Risk in Bone Correction
FDA (Devices) · 2023-02-22