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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Natural Nail Tibial Nail

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  Class 2 Device Recall Zimmer Natural Nail Tibial Nail see related information
Date Initiated by Firm July 30, 2018
Create Date September 25, 2018
Recall Status1 Terminated 3 on October 24, 2019
Recall Number Z-3246-2018
Recall Event ID 80879
510(K)Number K082770  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008

Product Usage - The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Tibial nails include the following in the tibia: Compound and simple shaft fractures Proximal, metaphyseal and distal shaft fractures Segmental fractures Comminuted fractures Fractures involving osteopenic and osteoporotic bone Pathological fractures Fractures with bone loss Pseudoarthrosis, non-union, mal-union and delayed union Periprosthetic fractures Surgically created defects such as osteotomies.
Product Usage - The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Tibial nails include the following in the tibia: Compound and simple shaft fractures Proximal, metaphyseal and distal shaft fractures Segmental fractures Comminuted fractures Fractures involving osteopenic and osteoporotic bone Pathological fractures Fractures with bone loss Pseudoarthrosis, non-union, mal-union and delayed union Periprosthetic fractures Surgically created defects such as osteotomies.
Code Information UDI: (01)00889024097551(17)190228(10)61169228R, Lot 61169228R
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact 411 Technical Services
574-371-3071
Manufacturer Reason
for Recall		 The item is labeled as an 8.3mm, but it is actually a 12 mm.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action On 7/30/18, Urgent Medical Device Recall notification letters were distributed to customers. Distributors were instructed to do the following: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals and surgeons within your territory. a. Complete Attachment 1  Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. b. Request a Return Authorization Number through zimmerbiometintlirarequests@zimmerbiomet.com for international returns c. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com d. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. e. Mark RECALL on the outside of the returned cartons. 4. Retain a copy of your Inventory Return Certification and product return forms for your records in the event of a compliance audit of your facility. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com. Risk Managers and Surgeons were asked to do the following: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1  Certificate of Acknowledgement an
Quantity in Commerce 1 unit
Distribution The product was not distributed in the United States. The product was distributed in the Netherlands.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HSB and Original Applicant = ZIMMER, INC.
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