Lactosorb RapidFlap — Class II medical device recall Z-1705-2018
Terminated recall by Zimmer Biomet, Inc., reported 2018-05-16, distributed in CA, FL, MO, NC, SC, TX, WI. The recalling firm has confirmed that the Outer Plate component exhibits an excessive chamfer on the threading
| Recall number | Z-1705-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2018-04-05 |
| Classified | 2018-05-09 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2020-08-12 |
| Distributed | CA, FL, MO, NC, SC, TX, WI |
| Countries outside the US | AR, CN, CO, DE, JP, NL, TH, VN, ZA |
| Quantity | 13,175 |
| Lot numbers | 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 and 297 more |
| Model numbers | 915-0020 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1705-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.