Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
- Company
- Orthopediatrics Corp
- Recall Initiated
- June 29, 2022
- Recall Number
- Z-1678-2022
- Quantity
- 640 units
- Firm Location
- Warsaw, IN
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
US Nationwide Distribution: AZ, AL, CA, FL, FL, MD, MO, NC, NY, TX Foreign: Australia
Lot / Code Info
UDI: 00841132179468 Lot Numbers: 239006-B and 238997-B
Root Cause
Process change control
Action Taken
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 jbatts@orthopediatrics.com or 574-367-5396.