Z-1678-2022Class II

Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN

Name: Z-1678-2022 Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
Creator: OrthoPediatrics Corp
Published: 2022-06-29
License: https://open.fda.gov/license/

Orthopediatrics Corp / initiated 2022-06-29 / Open, Classified / root cause: manufacturing process

FDA source

OrthoPediatrics Corp began a recall of Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN on 2022-06-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1678-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-29
Posted: 2022-09-06
Recalling firm: Orthopediatrics Corp
Product: Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
Product code: KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
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
Root cause tag: manufacturing process
FDA 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 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.
Quantity in commerce: 640 units
Distribution: US Nationwide Distribution: AZ, AL, CA, FL, FL, MD, MO, NC, NY, TX Foreign: Australia
Product codes and lots: UDI: 00841132179468 Lot Numbers: 239006-B and 238997-B

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1678-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1678-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-06

Product code KTT

K151881Class IIX-Fix Line AdditionsVilex IN Tennessee, Inc. / cleared 2016-03-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)