Recall Z-1297-2008 ยท HRS Plate, Fixation, Bone
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics, Locking Screw, T7, Catalog Number: 40-27622, Size: 2.7X22MM, Non Sterile,Titanium Alloy; Manufactured and Distributed by: Stryker Leibinger GmbH & Co. KG;Boetzinger Strasse 41; 0-79111 Freiburg, Germany
| Date | Mar 25, 2008 (initiated Jan 28, 2008) |
| Status | Terminated |
| Reason | Screws do not have locking threads |
| Root cause | Process control |
| Action | Recall notification letters (Urgent Product Recall) were sent on January 28, 2008 to all Stryker Branches/Agencies by Federal Express. All product distributed was requested to be located and returned, including from hospitals. |
| Quantity | 100 units |
| Distribution | Nationwide-USA including states of MA, PA, GA, OH, and TX (hospital consignees) and Stryker Branches/Agencies in MA, NJ, PA, MD, VA, NC, GA, TN, KY, OH, MI, LK, OK, TX, and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.