Recall Z-0011-06 ยท LXH Orthopedic Manual Surgical Instrument
Stryker Howmedica Osteonics Corp.
Allocraft TLIF Bone Inserter.
| Date | Oct 7, 2005 (initiated Apr 4, 2005) |
| Status | Terminated |
| Reason | Stryker was made aware that the short arm of the bone inserter may fracture during use and potentially result in an adverse health consequence. |
| Root cause | Other |
| Action | The firm sent notification letters to their branches/agencies on 4/4/2005. 100% effectiveness to be achieved by completing Product Accountability forms, follow up telephone calls, and follow-up letters as required. |
| Quantity | 9 |
| Distribution | The product was distributed to the firm''s branches/Agencies that distribute the product to hospitals, etc. There are 8 locations. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.