Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 recall
Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
Why was Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 recalled?
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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 00841132179468 Lot Numbers: 239006-B and 238997-B
- Product
- Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
- Recalling firm
- OrthoPediatrics Corp
- Quantity
- 640 units
- Distribution
- US Nationwide Distribution: AZ, AL, CA, FL, FL, MD, MO, NC, NY, TX Foreign: Australia
- Recall date
- September 14, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)