RETi-LOCK Cluster-Hole Acetabular Shells with Sealed Screw-holes manufactured by Zimmer, Austin, Texas
FDA device recall Z-0809-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Centerpulse Orthopedics, Inc
- Reason for recall
- Compalints of acetabular shell disassociating with the bone.
- Action taken
- The firm called and issued letters on September 30, 2003 informing physicians of a complaint received. The letter requested that the physicians discontinue use of the device until and investigation could be conducted. On 03/8/2004 the firm issued a letter to Zimmer distributors to return all inventory.
- Root cause
- Other
- Status
- Terminated
- Product code
- LZO
- Quantity affected
- 145 units
- Distribution
- Physicians in the following areas: CA, Washington D.C., MD, LA, ID, and WA
- Date initiated
- 2003-09-30
- Date posted
- 2004-07-20
- Date terminated
- 2004-11-04
- Location
- Austin, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ASCENDENT ACETABULAR SYSTEM (K022985) | Sulzer Orthopedics, Inc. | 2002-12-05 |