Recall Z-1635-2013 ยท HTW Bit, Drill
Surgical Instrument Service And Savings, Inc.
- Cannulated Drill Bit for Mini TightRope Ref. AR-8911DC Lot 122511 - Drill Bit, Straight Shank 2.7mm x 12.7cm Ref. 2318-027-00 Lot 122322 - Drill Bit, w/Depth Mark, Quick Coupling (Red) 2.0mm x 140mm Ref. 323.062 Lot 122347 - Fast Cutting Drill Bit 2.0mm Ref. FDB 2.0 Lot 122289, 122322 - Midas Rex Metal Cutting Drill Bit 3.0mm x 18.3mm Ref. MC30 Lot 122347 Orthopedic manual surgical inst
| Date | Jul 1, 2013 (initiated May 3, 2013) |
| Status | Terminated |
| Reason | The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. |
| Root cause | Packaging process control |
| Action | MEDISISS sent a Correction Immediate Action Request letter dated May 2, 2013, to all affected customes. The letter identified the product, the problem, and the action to be taken by the customer. The letter directed the customer to inspect the products prior to use for seal integrity as specified on the product labeling: "Sterile unless package has been damaged or opened. Do not use if package is damaged." This will be followed up by a visit from the customer's sales representatives who are tasked with inspecting all the lots that may be remaining in the customer's inventory. The sales r |
| Quantity | 10 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.