Titanium Hindfoot Arthrodesis Cannulated Nails Recalled Due to Sterilization Failure
Synthes recalls 13 mm Titanium Hindfoot Arthrodesis Cannulated Nails (5 units) due to failed sterilization. These surgical implants were distributed worldwide and pose infection risk if implanted.
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: This is a Class II recall of a surgical implant with confirmed lack of sterilization. Although no illnesses or injuries have been reported, non-sterilized implants used in surgical procedures represent a high risk of infection, fitting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Synthes (USA) Products LLC is recalling 13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX (Part Number 04.008.378S, Lot 41P2222) because the products in this lot are not sterilized and sterility cannot be confirmed. These surgical implants are intended to facilitate tibiotalcaneal arthrodesis fusion procedures used to treat severe foot and ankle deformity, arthritis, instability, and skeletal defects.
5 units were distributed worldwide, including throughout the United States and to the following countries: Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, and South Africa. Non-sterilized surgical implants intended for internal use pose an infection risk if implanted.
Healthcare providers and facilities that received this product should not use it and should contact Synthes for return and replacement instructions. Patients who may have received this implant should consult their healthcare provider.
The recalled product
- Product
- 13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. Part Number: 04.008.378S
- Manufacturer
- Synthes (USA) Products LLC
- Affected units
- 5
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 (1)
- UDI: 10886982087331 Lot Number: 41P2222
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Synthes (USA) Products LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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