FDA Medical Device Recalls (openFDA)
Howmedica Osteonics Corp dba Stryker Craniomaxillofacial: MEDPOR PLUS SST EZ 22mm Sphere Implant, Howmedica Osteonics Corp, 15 Dart Road, Newnan, GA 30265. MEDPOR PLUS Orbital Implants are intended to restore the volume of an enucleated or eviscerated eye globe.
- Recall number
- Z-1435-2012
- Recalling firm
- Howmedica Osteonics Corp dba Stryker Craniomaxillofacial
- Product
- MEDPOR PLUS SST EZ 22mm Sphere Implant, Howmedica Osteonics Corp, 15 Dart Road, Newnan, GA 30265. MEDPOR PLUS Orbital Implants are intended to restore the volume of an enucleated or eviscerated eye globe.
- Status
- Terminated
- Initiated
- 2012-03-20
- Posted
- 2012-04-18
- Terminated
- 2012-08-10
- Reason
- The MEDPOR PLUS SST EZ 22mm sphere implants are not within specification of 22mm +/- 8, therefore implant is not easily released from the syringe.
- Root cause
- Process control
- Action
- The sole distributor was notified by "Urgent Product Recall" letter on March 20, 2012. "Urgent Medical Device Recall" letters were sent to Stryker Customers on March 26, 2012. The letters described the product issue, hazards, and actions recommended to mitigate the risk. Customer number provided: (800) 962-6558.
- Quantity
- 31 units
- Distribution
- US Distribution, the state of Michigan.
- Lot, serial or model codes
- Catalog number: 80062, Lot Codes: F000689 and G004528.
- 510(k) numbers
- ["K021357"]
- PMA numbers
- not on file
- Product code
- HPZ
- Firm FEI
- 1000131961
- Firm city
- Newnan
- Firm state
- GA
- 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