Class 2 Device Recall Lactosorb RapidFlap

• Date Initiated by Firm: April 05, 2018
• Date Posted: May 07, 2018
• Recall Status: Terminated on August 12, 2020
• Recall Number: Z-1705-2018
• Recall Event ID: 79987
• 510(K)Number: K003281
• Product Classification: Plate, bone - Product Code JEY
• Product: Lactosorb RapidFlap, bone plate, Model No. 915-0020; ; The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.
• Code Information: Lots 013040 013050 013060 013070 013080 013090 013100 013120 013130 013140 013150 025720 038090 038100 038110 038120 038130 038160 038170 038200 038210 038220 038230 054050 054070 054080 054090 054110 075970 089200 089210 108270 108280 110830 110840 110860 110870 110900 110910 110920 110930 110940 110950 110980 110990 111000 111010 111020 111030 111070 144270 144280 147300 147350 165500 165510 173190 173210 173220 173230 173260 173270 173280 173290 173300 173320 173340 218330 218340 255340 255370 264730 264750 264760 264770 264780 291390 291400 293380 293390 293400 293410 293470 293480 315430 315450 315460 315470 315500 315520 315530 315540 315560 331750 331800 331820 331840 331850 331880 335580 335590 335600 335610 348850 348860 348870 379760 379800 379810 379870 379920 389450 389460 389470 404640 404650 404660 443260 443270 443280 444360 444380 444390 444400 444420 456140 456340 456350 456370 467210 467220 469270 469280 469300 469310 471700 471720 471760 479790 479810 479820 479840 480560 480620 480660 508530 508540 525820 525830 525850 525860 543340 543370 543380 543390 543400 550440 550450 550460 550470 559890 559900 559910 559920 559930 559950 559960 559980 559990 562220 562230 562240 562260 563380 563390 563400 581190 581200 669150 669160 669180 669190 669200 675730 676640 676650 676720 676730 676740 676750 676760 676780 676790 676800 676820 676830 676840 676850 691060 691100 691110 691230 691240 691250 691290 691300 691320 701210 701220 701230 701240 701250 701270 701280 715290 715300 715310 715320 715330 715340 788400 788410 788420 788430 788440 792970 792990 793000 793010 793050 793080 793090 793100 810070 810100 810110 835080 835090 835100 835110 835120 835140 875960 876060 876070 876090 876100 876110 876120 876130 876150 898160 898170 898200 898240 898260 898320 898360 914430 914450 914460 930760 930780 930810 930840 930850 930860 930870 946980 947030 947070 991710 991740 991760 991770 991780 997070 997110 997120 997130 997150 997160 997170 997190 997260 997300 997320 997340 997360 997390 997400 997410 (Updated 3/20/19) Expanded Lots: 538220 593400 331850 538510 593410 379800 538880 593430 691290 538900 615370 054070 538940 615380 110860 662300 615390 110900 699490 615400 110940 699600 615410 111030 991750 615420 173290 379730 615630 218330 379910 662320 218340 538120 662330 331750 538180 662370 331820 538250 662380 331840 538310 699470 331880 538370 699500 379760 538480 699520 379810 538520 699540 379870 538610 699560 379920 538630 699570 444380 538660 699580 676830 538680 699590 835110 538920 110910 997260
• Recalling Firm/ Manufacturer: Zimmer Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• For Additional Information Contact: 411 Technical Services; 574-371-3071
• Manufacturer Reason for Recall: The recalling firm has confirmed that the Outer Plate component exhibits an excessive chamfer on the threading after deburring operations. This excessive chamfer results in non-conforming product where the threads of the outer plate component have limited to no engagement with the post component.
• FDA Determined Cause: Process control
• Action: Zimmer Biomet sent an Urgent Medical Device Recall letter dated April 5, 2018, to Distributors, Sales Representatives, and Distribution Managers. A separate recall letter was sent to Risk Managers on the same date. (Updated 3/20/19) On February 12, 2019, the firm issued notification of recall expansion. Further affected lots had been identified as part of the recall, and affected customers were notified. (/Update) Consignees were informed of the product issue and risk of non-functioning device and delays in surgery. All parties were instructed to review the notice, locate and quarantine affected product in inventory, return all affected product with a completed return form and mark "RECALL" on the outside of returned cartons, and return the completed customer response form. If you have further questions or concerns regarding this recall, please call (904)741-4400 extension 9133 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of operating hours will receive a voicemail prompt. For further questions, please call (574) 371-3071. (Updated 3/20/19) Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com. (/Update)
• Quantity in Commerce: 13175
• Distribution: worldwide Distribution - US Distribution to the states of : CA, FL, MO, NC, SC, TX, and WI., and to the countries of : Argentina, China, Colombia, Germany, Japan, Netherlands, South Africa, Thailand, and Vietnam.
• 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 = JEY and Original Applicant = BIOMET, INC.