Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
Summary
The FDA issued a Class II for Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN by OrthoPediatrics Corp. Reason: Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The fractured tip may be retained in the patient.
Details
Source
Device Recall
External ID
Z-1678-2022
Action Date
2022-09-14
Status
Ongoing
Category
device
Product Description
Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
Lot/Code Info: UDI: 00841132179468 Lot Numbers: 239006-B and 238997-B
Quantity Affected: 640 units
Reason for Recall
Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The fractured tip may be retained in the patient. Retrieval attempts may be made which could result in a delay of surgery and potentially damage soft tissue and increase healing time
Distribution
US Nationwide Distribution: AZ, AL, CA, FL, FL, MD, MO, NC, NY, TX Foreign: Australia
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-29
Company
Warsaw, IN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 134 device recalls issued in the same week, part of 403 device-related FDA actions this month.
OrthoPediatrics Corp has 15 FDA actions in our database, including 2 recalls and 13 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (OrthoPediatrics Corp) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does OrthoPediatrics Corp have FDA actions?
OrthoPediatrics Corp has 15 FDA actions in our database, including 2 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1678-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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