FDA Device recall Z-1705-2018
Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy f…
- FDA Device
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy f… by Zimmer Biomet, citing 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-co….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1705-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-05 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | CA, FL, MO, NC, SC, TX, WI |
Product
Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.
Reason
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.
Identifiers
| code_info | Lots 013040 013050 013060 013070 013080 013090 013100 013120 013130 013140 013150 025720 038090 038100 03…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 444 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1705-2018%22
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