Endobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material, used in dental and/or surgical procedures.

FDA device recall Z-0788-2016 · posted 2016-02-09 · Terminated

Recall details

Recalling firm

Biomet France SARL

Reason for recall

Cytotoxicity tests were not passed at 36 months. Use of Endobon-Xenograft Granules past 18 months of its specified shelf life may result in patient illness/injury.

Action taken

Zimmer BIOMET France SARL has initiated a voluntary recall via certified mail on January 2, /2016 for the Endobon Xenograft Granules, based on limited (in vitro/bench) results which indicated cytotoxicity tests were not passed at 36 months (real-time) aging. Use of the Endobon Xenograft Granules may result in patient may experiencing soft tissue irritation, up to and including infection. Customers area asked to do the following: 1. Please review this notice. 2. Identify, remove from service and segregate all affected Endobon ROX* product in your inventory. 3. Complete the attached Business Reply Form (Attachment 1) and: a. Fax it to 877-650-0368 or email it to Biomet5351@stericycle.com. 4. If you have product to return, contact BIOMET 3i at the number on the Business Reply Form for an RMA number and return shipping label. a. Return a copy of the Business Reply Form along with any affected product to the address on the Business Reply Form. Replacement product will immediately ship based upon availability. For assistance or other questions that customers may have relative to this notice, please contact BIOMET 3i at 1-800-443-8166 or 1-561-776-6700. Team members are available to assist you 8:00am to 6:00pm (Eastern), Monday through Friday.

Root cause

Under Investigation by firm

Status

Terminated

Product code

LYC

Quantity affected

145,116 units

Distribution

Worldwide Distribution - US including AL, AK, AR, AK, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MN, MI, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD

Date initiated

2016-01-21

Date posted

2016-02-09

Date terminated

2017-05-31

Location

France

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