FDA Medical Device Recalls (openFDA)
Centerpulse Orthopedics, Inc: RETi-LOCK Cluster-Hole Acetabular Shells with Sealed Screw-holes manufactured by Zimmer, Austin, Texas
- Recall number
- Z-0809-04
- Recalling firm
- Centerpulse Orthopedics, Inc
- Product
- RETi-LOCK Cluster-Hole Acetabular Shells with Sealed Screw-holes manufactured by Zimmer, Austin, Texas
- Status
- Terminated
- Initiated
- 2003-09-30
- Posted
- 2004-07-20
- Terminated
- 2004-11-04
- Reason
- Compalints of acetabular shell disassociating with the bone.
- Root cause
- Other
- Action
- 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.
- Quantity
- 145 units
- Distribution
- Physicians in the following areas: CA, Washington D.C., MD, LA, ID, and WA
- Lot, serial or model codes
- Lot numbers: 1548942, 1548943, 1548944, 1548947, 1548948, 1548949, 1548950, 1553246, 1553248, 1553251, 1553252, 1553254, 1553259, 1553261, 1553262, 1553265, 1553266, 1553268, and 1553269
- 510(k) numbers
- ["K022985"]
- PMA numbers
- not on file
- Product code
- LZO
- Firm FEI
- 2935620
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28