MEDPOR BARRIER Sheets Rectangle Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for no
FDA device recall Z-1092-2015 · posted 2015-02-11 · Terminated
Recall details
- Recalling firm
- Stryker Craniomaxillofacial Division
- Reason for recall
- Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaking intra-operatively.
- Action taken
- Stryker sent an Urgent Medical Device Recall Notice dated December 23, 2014, to all affected customers with a response form to be completed and returned upon receipt and review. The letter identified the affected product, potential hazards, risk mitigation and the actions to be taken. For questions contact Stryker CMF at 1-800-962-6558, or e-mail at CMF-custserv@stryker.com.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FWP
- Quantity affected
- 1051
- Distribution
- Worldwide Distribution - US Nationwide in the states of PA, KY, VA, CT, UT, MD, AR, FL, TX, AL, DE, IL, IA, MI, CO, OH, GA, CA, DC, MO, LA, WI, ID, SC, NC, NY, MA, NH, CA, OK, MN, KY, IN, OR, TN and t
- Date initiated
- 2014-12-17
- Date posted
- 2015-02-11
- Date terminated
- 2015-11-06
- Location
- Portage, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL (K952677) | Porex Surgical, Inc. | 1995-08-21 |