Recall Z-1678-2022 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
OrthoPediatrics Corp
Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
| Date | Jun 29, 2022 |
| Status | Open, Classified |
| 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 |
| Root cause | Process change control |
| Action | OrthoPediatrics Corp. provided Urgent Medical Device recall Letter to Distributors on 6/29/22. Letter states reason for recall, health risk and action to take: The affected product must be returned to OrthoPediatrics Corporation. Replacement product will be provided. Please contact customer service to arrange return of the affected product. Distributors should retrieve affected product that may be with customers. No additional corrective actions need to be taken for product already implanted. Please complete and return the attached response acknowledgement form confirming your understanding o |
| Quantity | 640 units |
| Distribution | US Nationwide Distribution: AZ, AL, CA, FL, FL, MD, MO, NC, NY, TX Foreign: Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151881 | X-Fix Line Additions Vilex IN Tennessee, Inc., Mar 24, 2016 |