Reported Sep 14, 2022 · Ongoing
Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
OrthoPediatrics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: OrthoPediatrics Corp · 2850 Frontier Dr · Warsaw, IN · 46582-7001
Is this the product you have?
- Orthex External Fixation Wire Sharp Bayonet 1.8
- x 400 mm ModelK400-18BN
- Lot codes and dates
- UDI00841132179468
- Lot Numbers239006-B and 238997-B
- Amount recalled
- 640 units
Where it was sold
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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