Recall Z-1092-2015
Stryker Craniomaxillofacial Division · initiated December 17, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
MEDPOR BARRIER Sheets Rectangle Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER Implants are intended for the augmentation or restoration of bony contour in the craniofacial skeleton.
Codes / lots: Part Number 9312; Lot Number A1403008
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.
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-1092-2015
- Initiated
- December 17, 2014
- Posted by FDA
- February 11, 2015
- Terminated
- November 6, 2015
- Product code
- FWP – Prosthesis, Chin, Internal
- Quantity
- 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 the countries of: Argentina, Australia, Canada, Chile, China, Netherlands, France, Spain, South Korea, Colombia, Switzerland, Singapore, and South Africa.
- Recalling firm
- Stryker Craniomaxillofacial Division, Portage, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1090-2015 Class II | MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot Numbers…Potential for implant damage, implant cracking off/breaking intra-operatively. | 12/17/2014Terminated |
| Z-1091-2015 Class II | MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR Implants in block…Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion… | 12/17/2014Terminated |
| Z-1093-2015 Class II | MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right…Article #81036 (MEDPOR Titan Max OFW - MTB - Right) reportedly contained article #81035 MEDPOR Titan Max OFW… | 12/17/2014Terminated |