D-Clip Applier Recalled for Failure to Release During Surgery
Peter Lazic GmbH's D-Clip Standard/Mini Applier is being recalled after a customer complaint that the device failed to release the clip during surgery, with the applier remaining attached to the clip.
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 an FDA Class II medical device with a documented failure mode during actual use—the applier failed to release the clip during surgery. While the source does not report any injuries or hospitalizations, the failure of a surgical device to function as designed during a procedure represents a significant risk-of-harm scenario.
Plain-English summary
The D-Clip Standard/Mini Applier is a 210mm bayonet surgical applier with a rigid jaw and double-action mechanism. The FDA is recalling this device (Model 35.411, UDI/DI 04250603739609), manufactured by Peter Lazic GmbH, following a customer complaint reporting that the applier failed during surgery. Specifically, the applier did not release the clip and remained attached to it.
All lot numbers of the affected device are included in this recall. A total of 63 units were distributed throughout the United States, with confirmed distribution to Maine.
This recall is classified as a Class II device recall by the FDA.
The recalled product
- Product
- D-Clip Standard/Mini Applier, 210mm bayonet, jaw rigid, double action.
- Manufacturer
- Peter Lazic Gmbh
- Affected units
- 63
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: 35.411
- UDI/DI: 04250603739609
- 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.
See all 3 products in this recall →Related recalls
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