Orthopedic inserter adapters recalled over weld breakage between pin and holder
Ortoma Inserter Adapter OTD devices are recalled because of a weld breakage between the pin and the inserter holder. 261 devices 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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; a weld breaking in a surgical inserter is a potential harm and no injuries are reported.
Plain-English summary
Ortoma Inserter Adapter OTD devices are being recalled, including the Inserter Adapter OTD Straight REF 30-201 (model 2001, UDI-DI 07350137521019), the Inserter Adapter OTD Pinnacle Straight REF 30-202 (model 1001, UDI-DI 07350137520593) and the Reamer Adapter OTD listed in the recall notice. Affected lots include 20244803. The recall covers 261 devices distributed in Florida and in Japan and Sweden.
The recall was issued because of a weld breakage between the pin and inserter holder of the Inserter Adapter. The FDA classified the action as Class II.
Hospitals and surgical centres holding these devices should quarantine them and follow the manufacturer's instructions for return or replacement.
The recalled product
- Product
- Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 Inserter Adapter OTD Pinnacle Straight REF 30-202 Model Number: 1001 UDI-DI code: 07350137520593 Reamer Adapter OTD REF 30-157 Model Number: 1003…
- Manufacturer
- ORTOMA AB
- Affected units
- 261
Distribution
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