MEDPOR PLUS SST EZ 22mm Sphere Implant, Howmedica Osteonics Corp, 15 Dart Road, Newnan, GA 30265. MEDPOR PLUS Orbital Im
FDA device recall Z-1435-2012 · posted 2012-04-18 · Terminated
Recall details
- Recalling firm
- Howmedica Osteonics Corp dba Stryker Craniomaxillofacial
- Reason for recall
- The MEDPOR PLUS SST EZ 22mm sphere implants are not within specification of 22mm +/- 8, therefore implant is not easily released from the syringe.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HPZ
- Quantity affected
- 31 units
- Distribution
- US Distribution, the state of Michigan.
- Date initiated
- 2012-03-20
- Date posted
- 2012-04-18
- Date terminated
- 2012-08-10
- Location
- Newnan, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT (K021357) | Porex Surgical, Inc. | 2002-08-05 |