Recall Z-1862-2011 ยท HTJ Gauge, Depth
Stryker Howmedica Osteonics Corp.
Xcelerate Specialty Patella Milling System Per File K2399; Catalog Number I-K2399PR00, I-K2399PR10; Stryker Howmedica Osteonics, Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 The Xcelerate patella milling system (as detailed in surgical protocol LSPK35) was designed to prepare a patella to accept all Scorpio or Duracon patellar implants using either a resurfacing or recessed te
| Date | Mar 31, 2011 (initiated Jan 27, 2011) |
| Status | Terminated |
| Reason | Stryker Orthopaedics has become aware that the 10 mm on the bone remaining depth gage is incorrect thus allowing for the reamer to leave as little as 8.9mm (in a nominal condition) patella bone. |
| Root cause | Device Design |
| Action | Stryker sent an Urgent Product Recall letter dated January 27, 2011, via FedEX for January 28, 2011, delivery with return receipt. The letter identified the product, the problem, and the action to be taken by the customer. Customers were insructed to fax back the attached Product Recall Acknowledgement Form within 5 days to 201-831-6069. Customers were also instructed to contact the hospitals in their territory that have the affected product to arrange return of the product. Product should be returned to the attention of: Regulatory Compliance Stryker Orthopaedics 325 Corporate Drive M |
| Quantity | 52 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.