Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
Recall
- Recall Number
- Z-1678-2022
- Event Number
- 90738
- Firm
- OrthoPediatrics Corp
- FEI Number
- 3006460162
- Product Code
- KTT
- Status
- Open, Classified
- Root Cause
- Process change control
- Initiated
- June 29, 2022
- Address
- 2850 Frontier Dr, Warsaw, IN, 46582-7001
Description
Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
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
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 of these instructions. Any questions regarding this recall can be directed to Joel Batts, Senior VP of Science & Technology, at OrthoPediatrics at [email protected] or 574-367-5396.
US Nationwide Distribution: AZ, AL, CA, FL, FL, MD, MO, NC, NY, TX Foreign: Australia
640 units