Recall record at a glance
| Official record | Z-1569-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Aesculap Implant Systems LLC |
| Report date | May 17, 2023 |
| Recall initiation date | Mar 21, 2023 |
| Quantity | 6 pieces |
| Location | Center Valley, PA, United States |
Official product description
Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery. Product Code: PL771SU
Why the product was recalled
Potential for the spring to become loose and fall out of the device, if the spring falls out during a surgical procedure, it may enter the patient's body.
Distribution information
US Nationwide distribution in the state of OH.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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