Stryker Craniomaxillofacial Division: Medical Device Recall in 2015 - (Recall #: Z-1090-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.
Product Description:

MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot Numbers A1405048, A1404026 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.

Product Classification:

Class II

Date Initiated: December 17, 2014
Date Posted: February 18, 2015
Recall Number: Z-1090-2015
Event ID: 70166
Reason for Recall:

Potential for implant damage, implant cracking off/breaking intra-operatively.

Status: Terminated
Product Quantity: 1051
Code Information:

Part Number 86001; Lot Numbers A1405048, A1404026

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated