Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
Reported: September 14, 2022 Initiated: June 29, 2022 #Z-1678-2022
Product Description
Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
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
Details
- Recalling Firm
- OrthoPediatrics Corp
- Units Affected
- 640 units
- Distribution
- US Nationwide Distribution: AZ, AL, CA, FL, FL, MD, MO, NC, NY, TX Foreign: Australia
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN. Recalled by OrthoPediatrics Corp. Units affected: 640 units.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 14, 2022. Severity: Moderate. Recall number: Z-1678-2022.
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