Short Barrel Sideplate, Omega + 140 degrees, 4 slots; The Omega Plus Compression Screw system consists of a series of la
FDA device recall Z-1865-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker Orthopaedics became aware that the packaging labeled as catalog number 3362-0-040; lot code E00985, 140 x 4 slot may contain a 5 hole slot.
- Action taken
- Stryker branches and agencies were notified by letter on January 25, 2005. Letters to branches were notified of the packaging error and asked that all inventory location be examined to identify product. Product was to be returned to Stryker. If the product was further distributed, letters were provided to be sent to hospital OR Supervisors. A reconciliation form was also included and asked to be completed and returned. For information on this recall contact Rita Intorella at 201-831-5825.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KTT
- Quantity affected
- 20 units
- Distribution
- To Stryker branches and hospitals nationwide.
- Date initiated
- 2005-01-25
- Date posted
- 2008-09-16
- Date terminated
- 2008-09-24
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OMEGA+ COMPRESSION SCREW SYSTEM (K955306) | Howmedica Corp. | 1996-04-10 |
| MEGA PLUS SUPER LAG SCREW (K930156) | Pfizer Hospital Products Group, Inc. | 1994-02-22 |
| OMEGA PLUS COMPRESS HIP SCREW SYSTEM, MODIFICATION (K922295) | Howmedica Corp. | 1992-09-08 |
| MODIFIED OMEGA COMPRESSION HIP SCREW SYSTEM (K872223) | Howmedica Corp. | 1987-06-26 |
| COMPRESSION HIP SCREW SYSTEM (K850886) | Pfizer, Inc. | 1985-04-19 |