Hintermann left talar implant packaging contained a right-side device
Hintermann Series Talar Implants, Left, Size 2, are being recalled because packaging and labeling for a left implant contained a right implant device. 67 units are affected.
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 where the wrong-sided implant is inside correctly labelled packaging, a risk of harm with no injuries reported in the source.
Plain-English summary
The Hintermann Series Talar Implant, Left, Size 2, REF 302112, from DT MedTech, LLC, is being recalled. The action covers 67 units in lot AACAA, DI B095302112.
Through customer complaints, the ankle replacement system was found to contain incorrect devices: left implant packaging and labeling bears a right implant device. The FDA classified the action as Class II.
Distribution was worldwide, including within the United States in California, Arkansas, Arizona and Idaho, and to Peru and South Korea. The implants are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the REF, lot and DI above, quarantine it, and follow the instructions issued by DT MedTech.
The recalled product
- Product
- Hintermann Series Talar Implant, Left, Size 2 REF 302112
- Manufacturer
- DT MedTech, LLC
- Category
- Medical Device — Ankle implant
- Affected units
- 67
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)
- Lot: AACAA/ DI: B095302112
Distribution
Related recalls
Same manufacturer · DT MedTech, LLC
See all →- ModerateDT MedTech Recalls Ankle Joint Inlays Due to Incorrect Package Labeling
FDA (Devices) · 2018-11-14
- ModerateDT MedTech Recalls Ankle Implant Due to Incorrect Package Labeling
FDA (Devices) · 2018-11-14
Same hazard · wrong device
See all →- HighOrthopedic Shoulder Implant Devices Recalled Due to Packaging Mix-Up
FDA (Devices) · 2023-11-15
- HighMerit Medical Recalls Pediatric Peritoneal Dialysis Catheters Due to Mix-Up
FDA (Devices) · 2018-08-22
- ModerateDePuy Orthopaedics Recalls CORAIL COXA VARA High Offset Stem Due to Packaging Error
FDA (Devices) · 2018-02-21
- ModerateSt. Jude Medical Recalls Electrophysiology Catheters Due to Incorrect Packaging
FDA (Devices) · 2014-11-12
Similar recalls
- ModerateDT MedTech Recalls Ankle Implant Due to Incorrect Package Labeling
FDA (Devices) · 2018-11-14
- ModerateDT MedTech Recalls Ankle Joint Inlays Due to Incorrect Package Labeling
FDA (Devices) · 2018-11-14
- ModerateIntegra Talar Dome Total Ankle Prosthesis Recalled for Incorrect Labeling
FDA (Devices) · 2019-04-24
- ModerateIntegra Talar Dome Ankle Prosthesis Recalled for Incorrect Labeling
FDA (Devices) · 2019-04-24
- ModerateIntegra Talar Dome Total Ankle Prosthesis Recalled for Labeling Error
FDA (Devices) · 2019-04-24
- ModerateIntegra Recalls Salto Talaris Ankle Prosthesis Due to Labeling Error
FDA (Devices) · 2019-04-24