FDA Device recall Z-1660-2020
BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412
- FDA Device
- Class II
- terminated
- Published 2020-04-15
On 2020-04-15 the FDA classified a Class II recall of BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412 by Biomet, citing potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1660-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-02-26 |
| Published | 2020-04-15 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Biomet |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY |
Product
BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.
Reason
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Identifiers
| code_info | ***Lot Numbers*** 860910, 215450, 555580, 583860, 089700, 102920, 283420, 148680, 503890, 954890, 097260, 3…***Lot Numbers*** 860910, 215450, 555580, 583860, 089700, 102920, 283420, 148680, 503890, 954890, 097260, 325340, 409370, 409450, 409490, 851280, 234350, 452060, 706850, 257410, 709790, 967440, 079230, 262250, 458790, 728540, 172680, 533270, 776910, 020620, 196040, 526700, 751880, 988270, 115360, 282070, 410360, 908940, 978030, 978040, 313260, 313270, 089530, 089540, 637400, 637410, 685000, 398240, 398250, 398280, 398260, 877310, 877320, 877330, 202540, 398260R, 555580R, 398240R, 674430, 809060, 747370, 916210, 916220, 262250R, 877320R, 349570, 914620, 914630, 962810, 963780, 005670, 035060, 399640, 399660, 399670, 399680, 417040, 417060, 417070, 308170, 705200, 694850, 736560, 372280, 064920, 637410R, 186470. ***UDI Numbers*** (01)00880304551008(17)141007(10)860910, (01)00880304551008(17)141112(10)215450, (01)00880304551008(17)181231(10)555580, (01)00880304551008(17)181231(10)583860, (01)00880 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1660-2020%22
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