Food, drugs, devices › Aesculap Implant Systems LLC
Device recall: Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
Aesculap Implant Systems LLC (Center Valley, PA) initiated this device recall on 1 Aug 2016; FDA lists 1 product record under event 75142, classified Class II.
FDA defines Class II as 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. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 16 Feb 2018. Initiation: voluntary: firm initiated. Aesculap Implant Systems LLC has 35 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Aesculap Implant Systems LLC, Center Valley, PA.
Reason for recall
"There is a potential for the needle to detach from the suture thread during surgery. If the needle becomes detached the defective suture will need to be replaced causing the wound to be sutured a second time."
Distribution
"Distributed in Arizona"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0316-2017 | Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture | 180 units | Class II | Terminated | 2 Nov 2016 |
Context
Other enforcement events for Aesculap Implant Systems LLC
All 35 events for Aesculap Implant Systems LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "There is a potential for the needle to detach from the suture thread during surgery. If the needle becomes detached the defective suture will need to be replaced causing the wound to be sutured a second time."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed in Arizona"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 16 Feb 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.