Recall Z-0804-2012 ยท LXH Orthopedic Manual Surgical Instrument
Stryker Howmedica Osteonics Corp.
Brand Name: Custom Straight Accolade Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument Brand Name: Specialty Straight Command Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument Brand Name: Custom Straight Accolade Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument Brand Name: Custom Accolade Broach Handle Commo
| Date | Jan 18, 2012 (initiated Aug 19, 2011) |
| Status | Terminated |
| Reason | Stryker Orthopaedics has become ware that there is the potential for the above referenced instruments to fracture in two pieces along the width of the body under the striking plate. |
| Root cause | Process control |
| Action | Stryker Orthopaedics sent a Urgent Product Recall update dated August 18, 2011, via FedEx to all affected customers. The letter identified the product(s) the problem and the action needed to be taken by the customer. Our records indicate that you have received the above referenced product(s). It is Stryker's responsibility as the manufacturer to ensure that customers who may have received these affected products also receive this important communication. Please assist us in meeting our regulatory obligation by faxing back the attached Product Recall Acknowledgment Form within 5 days to 201-8 |
| Quantity | 106 UNITS |
| Distribution | USA (nationwide distribution) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.