Recall Z-2610-2014 ยท GAG Stapler, Surgical
Ethicon Endo-Surgery Inc
PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35), PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35), Bulk/Non-Sterile PROXIMATE RH Rotating-Head Skin Stapler (Model CK 117), and Bulk/Non-Sterile PROXIMATE PX Fixed-Head Skin Stapler (Model CK 158). Skin stapler for use in a single patient, which is designed to apply rectangular stainless steel staples for routin
| Date | Sep 8, 2014 (initiated Aug 12, 2014) |
| Status | Terminated |
| Reason | The device may have a non-conforming component that may cause the device to fire an unformed staple. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Ethicon Endo-Surgery, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated August 25, 2014 to its customers via overnight, UPS to allow tracking of the receipt. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine your inventory to determine if you have recalled product on hand; remove the recalled product and communicate the issue to relevent staff; complete and return Business Reply Form (BRF) confirming receipt of this notice within three (3) business days, indicating whether they have affected product, how much an |
| Quantity | 42,798 |
| Distribution | Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY; and countries of: Armenia, Belgium, Germany, Denmark, Finla |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.