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MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm recallZ-1090-2015 · Stryker Craniomaxillofacial Division · initiated Dec 17, 2014

Class II Terminated All recalls posted in February 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stryker Craniomaxillofacial Division or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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].

Recall details

Recall number
Z-1090-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Dec 17, 2014
Posted by the FDA
Feb 11, 2015
Recalling firm
Stryker Craniomaxillofacial Division
Quantity
1051
Product code
FWP
FDA submissions
K922489
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 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.

Code information (models, lots, serial numbers)

Part Number 86001; Lot Numbers A1405048, A1404026

Other devices under the same FDA submission

9 devices cleared under K922489 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 70166).

Sources and updates

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