CLASS II Device recall · Reported 18 Feb 2015 · FDA Enforcement Report

Medpor Barrier Sheets Orbital Floor Implant recalled

Stryker Craniomaxillofacial Division is recalling Medpor Barrier Sheets Orbital Floor Implant, distributed nationwide in the US. The recall was initiated on 17 Dec 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number 9305; Lot Numbers 69698, 77004, 81799, A1310051, A1311008, A1311044, A1312011, A1402023, A1404010

Quantity recalled1051

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1091-2015
FDA event ID: 70166
Recalling firm: Stryker Craniomaxillofacial Division, Portage, MI
Classification: Class II
Status: Terminated
Recall initiated: 17 Dec 2014
FDA classified: 11 Feb 2015
Reported: 18 Feb 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Surgical Instruments

Timeline

17 Dec 2014	Recall initiated by company
11 Feb 2015	Classified by FDA	+56 days
18 Feb 2015	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Alabama Arkansas California Colorado Connecticut District of Columbia Delaware Florida Georgia Iowa Idaho Illinois Indiana Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri

Questions about this recall

Why was it recalled?

Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaking intra-operatively.

Which lots are affected?

Part Number 9305; Lot Numbers 69698, 77004, 81799, A1310051, A1311008, A1311044, A1312011, A1402023, A1404010

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 70166

This product is part of a recall event; the main page for the event is Medpor Barrier Sheets Rectangle recalled by Stryker Craniomaxillofacial.

Reported	Class	Recall	Company	Reason	Where
18 Feb 2015	CLASS II	Medpor Barrier Sheets Rectangle recalled by Stryker Craniomaxillofacial	Stryker Craniomaxillofacial Division	Potency & Assay	Nationwide
18 Feb 2015	CLASS II	Medpor Surgical Implant Contoured Two Piece Chin recalled	Stryker Craniomaxillofacial Division	Device Malfunction	Nationwide
18 Feb 2015	CLASS II	Medpor Titan Max Orbital Floor and Wall recalled	Stryker Craniomaxillofacial Division	Other	Nationwide

More recalls from Stryker Craniomaxillofacial Division

All 6

Reported	Class	Recall	Company	Reason	Where
14 Oct 2015Device	CLASS II	Disposable Paper, Medical Accessory, 100 DISP, Paper F recalled	Stryker Craniomaxillofacial Division	Sterility	MI
18 Feb 2015Device	CLASS II	Medpor Titan Max Orbital Floor and Wall recalled	Stryker Craniomaxillofacial Division	Other	Nationwide
18 Feb 2015Device	CLASS II	Medpor Surgical Implant Contoured Two Piece Chin recalled	Stryker Craniomaxillofacial Division	Device Malfunction	Nationwide
18 Feb 2015Device	CLASS II	Medpor Barrier Sheets Rectangle recalled by Stryker Craniomaxillofacial	Stryker Craniomaxillofacial Division	Potency & Assay	Nationwide
4 Sep 2013Device	CLASS II	Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc) recalled	Stryker Craniomaxillofacial Division	Packaging Defects	Nationwide

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All 3,809

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