Z-1678-2022 Class II Ongoing
FDA device recall Z-1678-2022 was initiated by OrthoPediatrics Corp on June 29, 2022 and is designated Class II. 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 resul… The recall status is ongoing. Affected quantity: 640 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 14, 2022
- Initiation Date
- June 29, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 640 units
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
Distribution Pattern
US Nationwide Distribution: AZ, AL, CA, FL, FL, MD, MO, NC, NY, TX Foreign: Australia
Code Information
UDI: 00841132179468 Lot Numbers: 239006-B and 238997-B