Z-1091-2015Class II

MEDPOR BARRIER Sheets Orbital Floor Implant

Name: Z-1091-2015 MEDPOR BARRIER Sheets Orbital Floor Implant
Creator: Stryker Craniomaxillofacial Division
Published: 2014-12-17
License: https://open.fda.gov/license/

Stryker Craniomaxillofacial Division / initiated 2014-12-17 / Terminated / root cause: manufacturing process

FDA source

Stryker Craniomaxillofacial Division began a recall of MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing... on 2014-12-17. FDA classified it as Class II and gives the reason as "Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaking intra-operatively". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1091-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-17
Posted: 2015-02-11
Terminated: 2015-11-06
Recalling firm: Stryker Craniomaxillofacial Division
Product: MEDPOR BARRIER Sheets Orbital Floor Implant 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 code: FWP Prosthesis, Chin, Internal
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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 [email protected].
Quantity in commerce: 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.
Product codes and lots: Part Number 9305; Lot Numbers 69698, 77004, 81799, A1310051, A1311008, A1311044, A1312011, A1402023, A1404010

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1091-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1090-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-11
Z-1091-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-11
Z-1092-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-11
Z-1093-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-11

Product code FWP

K952677Class IIMedpor Barrier Surgical Implant BiomaterialPorex Surgical, Inc. / cleared 1995-08-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)