Recall Z-0788-2016
Biomet France SARL · initiated January 21, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Endobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material, used in dental and/or surgical procedures. Endobon Xenograft Granules, Bone Grafting Material, Synthetic are used in the following dental and/or surgical procedures: " Alveolar ridge augmentation/reconstruction, " Sinus elevation, " Filling of resection defects in benign bone tumor, bone cysts, or other defects in the alveolar ridge or wall, " Filling of bone defects after apicectomy, " Filling alveoli after tooth extraction. This product should not be used in non-peridontal mandibular applications.
Codes / lots: Item Numbers &Lot Numbers: ROX05 S016303 ROX05 S016304 ROX05 S0163056 ROX05 S0163059 ROX05 S0171051 ROX05 S017105R ROX05 S0171098 ROX05 T0001122 ROX05 T0001133 ROX05 T0001136 ROX05 T0001141 ROX05 T0001147 ROX05 T0025073 ROX05 T0034084 ROX05 T0045150 ROX05 T0045157 ROX05 T0052108 ROX05 T0064164 ROX05 T0064168 ROX05 T0064175 ROX05 T0096191 ROX05 T0104217 ROX05 T0104238 ROX05 T0114238 ROX05 T0122226 ROX05 T0122238 ROX05 T0134261 ROX05 T0134269 ROX05 T0142245 ROX05 T0142248 ROX05 T0162294 ROX05 T0183280 ROX05 T0192311 ROX05 T0192316 ROX05 T0205297 ROX05 T0214319 ROX05 T0224329 ROX05 T0224333 ROX05 T0224338 ROX05 T0224346 ROX05 T0224357 ROX05 T0234357 ROX05 T0245006 ROX05 T0245009 ROX05 T0254015 ROX05 T0266030 ROX05 T0273037 ROX05 T0273051 ROX05 T0281043 ROX05 T0281065 ROX05 T0281078 ROX05 T0291099 ROX05 T0291106 ROX05 T0291118 ROX05 T0291125 ROX05 T0291134 ROX05 U0013175 ROX05 U0025142 ROX05 U0025170 ROX05 U0035175 ROX05 U0055155 ROX05 U0055170 ROX05 U0084189 ROX05 U0084209 ROX05 U0092202 ROX05 U0092237 ROX05 U0102265 ROX05 U0114279 ROX05 U0124272 ROX05 U0132289 ROX05 U0132307 ROX05 U0132316 ROX05 U0141251 ROX05 U0141254 ROX05 U0141265 ROX05 U0153300 ROX05 U0171316 ROX05 U0181349…
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.
FDA-determined cause: Under Investigation by firm
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.
Details
- Recall number
- Z-0788-2016
- Initiated
- January 21, 2016
- Posted by FDA
- February 9, 2016
- Terminated
- May 31, 2017
- Product code
- LYC – Bone Grafting Material, Synthetic
- Quantity
- 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, TN, TX, UT, VA, WA, WI, WV and Internationally to Canada, Japan, Europe.
- Recalling firm
- Biomet France SARL