Recall Z-1678-2022— OrthoPediatrics Corp
Class II · Ongoing
Class II FDA medical device recall by OrthoPediatrics Corp, initiated 2022-06-29. It names one FDA 510(k) clearance: K151881. Product: Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN. 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. Retrieval attempts may be made which could result in a delay of surgery and potentially damage soft tissue and increase healing time.
- Recalling firm
- OrthoPediatrics Corp
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-06-29
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.