Recall Z-2084-2012 ยท LXH Orthopedic Manual Surgical Instrument
Stryker Howmedica Osteonics Corp.
Tibial Punch Tower Assembly. Non-Sterile. CAT NO. 8000-1089. Howmedica Osteonics Corp., 59 Route 17, Allendale, NJ 07401. During primary Scorpio TKA procedures, the Scorpio Tibial Punch Tower (8000-1089) is used in conjunction with Scorpio Tibial Keel Punches (3760-0305/-0709/-1113 and 3761-0305/-0709/-1113) and Tibial Templates (3750-0003/-0005/-0007/-0009/-0013) to prepare the tibia for b
| Date | Jul 26, 2012 (initiated Dec 22, 2011) |
| Status | Terminated |
| Reason | Stryker Orthopaedics received a report indicating that a Tibial Keel Punch could not be inserted into the slot of the Tibial Punch Tower. The slot that guides the stem of the keel punch into the channel of the tower was later determined to be undersized. |
| Root cause | Nonconforming Material/Component |
| Action | Stryker Orthopaedics sent an Urgent Product Recall/Recall Acknowledgement letter dated January 10, 2012, to all affected customers. The letter identified the product(s) the problem and the action needed to be taken by the customer. Customers were instructed to contact their Stryker Sales Representative to arrange for return of the affected product. Customers were asked to fax back the attached Product Recall Acknowledgement Form as soon as possible to 201-831-6069. For questions customers should call 201-972-2100. For questions regarding this recall call 201-831-5970. |
| Quantity | 152 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.