Wright Medical CHARLOTTE MTP Hex Screw Recall: Incorrect Product in Packaging
Wright Medical recalled 22 units of CHARLOTTE MTP Hex Screws with incorrect product in packaging. Affected lots 02010697711582590 and 02010697711582591 were distributed to surgical facilities in the US, Canada, Australia, Spain, UK, and Chile.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a surgical implant component with incorrect product in packaging. While no adverse events have been reported, using wrong components in foot and ankle reconstruction surgery poses a significant patient safety risk.
Plain-English summary
Wright Medical Technology, Inc. is recalling 22 units of the CHARLOTTE MTP Hex Screw, Model #41122718 (2.7mm x 18mm), a component used in the CHARLOTTE Lisfranc Reconstruction System for foot and ankle surgery. The screws from lots 02010697711582590 and 02010697711582591 were distributed with incorrect product contained in the packaging.
Affected units were distributed worldwide, including to surgical facilities and healthcare providers in Arizona, Iowa, and South Carolina in the United States, as well as Australia, Canada, Chile, Spain, and the United Kingdom. The GTIN for tracking is 00840420108340.
If you received units from the affected lot numbers, verify the contents match the packaging label and part number. Do not use any incorrectly packaged units in surgical procedures. Contact Wright Medical Technology, Inc. for instructions on returning the affected product or obtaining replacement screws.
The recalled product
- Product
- Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc Reconstruction System.
- Manufacturer
- Wright Medical Technology, Inc.
- Hazard
- Affected units
- 22
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot numbers 02010697711582590 and 02010697711582591
- GTIN 00840420108340.
Distribution
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