Medartis APTUS compression screws have off-centre cannulation in affected lots
Medartis APTUS 5.0 headed cannulated compression screws for bone fixation are being recalled because the cannulation of the screw is not centered. 13 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 a bone fixation implant is manufactured out of specification, a risk of harm with no injuries reported in the source.
Plain-English summary
The Medartis APTUS 5.0 headed CCS Long Thread 50/20 mm cannulated compression screw for bone fixation, REF A-8216.50/1, one per package, UDI-DI 07630037887706, is being recalled. The action covers 13 units.
The stated reason is that the cannulation of the CCS screw is not centered. The FDA classified the action as Class II.
Affected lot numbers are 25444702, 24425542, 24404471 and 25441997. Distribution was within the United States, in Louisiana, Texas, Indiana, California and North Carolina. The screws are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the REF, UDI-DI and lot numbers above, quarantine it, and follow the instructions issued by Medartis.
The recalled product
- Product
- Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation
- Manufacturer
- Medartis AG
- Affected units
- 13
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 (5)
- UDI/DI 07630037887706
- Lot Numbers: 25444702
- 24425542
- 24404471
- 25441997
Distribution
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