D-Clip Surgical Applier Recalled Due to Failure to Release During Surgery
A surgical clip applier from Peter Lazic Gmbh has been recalled after a reported failure to release the clip during surgery. The applier remained attached to the clip, potentially posing a safety risk during medical procedures.
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 risk-of-harm medical device where a documented failure occurred during surgery, but no injuries or illnesses have been reported. FDA Class II status with documented surgical instrument failure and no reported patient harm supports a High severity rating.
Plain-English summary
Peter Lazic Gmbh is recalling the D-Clip Standard/Mini Applier (Model 35.410) with a 190mm bayonet, rigid jaw, and double-action design.
A customer complaint reported that the applier failed during surgery, failing to release the surgical clip. The applier remained attached to the clip during the procedure. This failure could interfere with surgical outcomes or create additional risks during the medical procedure.
This recall affects 26 units of the affected model distributed nationwide in Maine.
Patients and healthcare providers who have used or currently have this device should consult with their surgeon or healthcare provider regarding the recall. Healthcare facilities with affected units should stop use and contact Peter Lazic Gmbh or the FDA for further guidance on handling and return of the device.
The recalled product
- Product
- D-Clip Standard/Mini Applier, 190mm bayonet, jaw rigid, double action.
- Manufacturer
- Peter Lazic Gmbh
- Affected units
- 26
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 (3)
- Model number: 35.410
- UDI/DI: 04250603739593
- All Lot numbers.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Peter Lazic Gmbh 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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