FDA Medical Device Recalls (openFDA)
Integrated Orbital Implants Inc: Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer
- Recall number
- Z-2292-2010
- Recalling firm
- Integrated Orbital Implants Inc
- Product
- Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer
- Status
- Terminated
- Initiated
- 2010-06-07
- Posted
- 2010-08-26
- Terminated
- 2010-08-31
- Reason
- Integrated Orbital Implants, Inc. has initiated a recall of it's Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer due to a labeling issue in which the expiration date of the product was omitted.
- Root cause
- Error in labeling
- Action
- Customers were contacted by telephone and email
- Quantity
- 40 units
- Distribution
- USA (MT, AL, IN, IA, NY, KY, IL, MI, and FL), Canada, Germany, and Turkey
- Lot, serial or model codes
- Lot# 528020R - Serial Numbers: 55839, 60778, 60848, 60957, 61391, 170021, 185765, 185766, 185768, 185769, 185946, 190014, 190015, 190018, 2004053, 2004578, 209584, 209585, 209586, 209587, 209611, 209627, 209628, 209629, 209631, 170022, 170023, 190019, 190021, 190025, 220048, 222535, 53049, 62327, 223207, 240031, 240032, 240039, 240040, 240048
- 510(k) numbers
- ["K982562"]
- PMA numbers
- not on file
- Product code
- HPZ
- Firm FEI
- 3009688114
- Firm city
- San Diego
- Firm state
- CA
- 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