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U.S. Department of Health and Human Services

Class 2 Device Recall Thinflap System Case

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  Class 2 Device Recall Thinflap System Case see related information
Date Initiated by Firm August 06, 2015
Create Date October 20, 2015
Recall Status1 Terminated 3 on October 13, 2017
Recall Number Z-0137-2016
Recall Event ID 72366
510(K)Number K121624  
Product Classification Plate, cranioplasty, preformed, alterable - Product Code GWO
Product Thinflap System Case
The cases hold surgical instrumentation in place during handling and storage.
Code Information Lot Code # 101465 Model # 19-5000
Recalling Firm/
Manufacturer		 Biomet Microfixation, LLC
1520 Tradeport Dr
Jacksonville FL 32218-2480
For Additional Information Contact Rachel Osbeck
904-741-9448
Manufacturer Reason
for Recall		 The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.
FDA Determined
Cause 2		 Component change control
Action Biomet Microfixation made phone calls on August 6, 2015 and an initial notice letter sent via FedEx on August 6, 2015, to all distributors. During the phone conversation the distributors confirmed that the inventory invoiced to them is currently in their possession and were asked to remove the lids from the trays and return them back to Biomet Microfixation. In conjunction to the Initial Notice, replacement lids were sent to their business address. Follow¿up communication would be distributed until all units are returned to Biomet Microfixation. Distributors were instructed to do the following: 1. Immediately locate and remove from circulation the items invoiced to your account as identified on this notice. 2. Remove the lids from the quarantined units and replace with the lids (15-5001-18 or 19-5001-18) received with this Initial Notice. The new lids are being distributed to address the issue with the trays. 3. Return the lids removed from the quarantined units to Zimmer Biomet CMF and Thoracic team with the labeling information provided with this notice. RETURN THIS LID: lot number(101337 or 101~65) located on the back of the lid DO NOT RETURN NEW LID: Part numbert 15-5001-18 or 1~5001-18 respectively 4. Use the FedEx label in this packet to return the lids; this will be Zimmer Biomet's method of tracking your return. If distributors have further distributed this product, they must notify the recipient of this action by providing the recipient a copy of this notice. This letter must be given to the personnel responsible for receiving field safety notices. Please understand it is your responsibility to locate and quarantine these products. Customers with questions were instructed to call at 1-800-874-7711 or 904-741-4400, extension 9574, Monday through Friday, 8am-4pm ET.
Quantity in Commerce 5 units
Distribution Nationwide Distribution including CA, FL, OK, NY, NC, and IL.
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 = GWO and Original Applicant = BIOMET MICROFIXATION
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