FDA recall Z-0302-2020

Product

Various Custom Devices, Item Nos. 32855090246 32855090252 32855090256 32855090265 32855090266 32855090270 32855090287 32855090290 32855090291 32855090297 32855090302 32855090317 32855090318 32855090319 32855090327 32855090329 32855090334 32855090336 32855090339 32855090348 32855090351 32855090352 32855090353 32855090354 32855090368 32855090369 32855090375 32855090376 32855090395 32855090396 32855090402 32855090409 32855090414 32855090434 32855090437 32855090439 32855090448 32855090450 32855090465 32855090484 32855090496 32855090497 32855090498 32855090501 32855090507 32855090512 32855090519 32855090520 32855090531 32855090543 32855090576 32855090585 32855090586 32855090593 32855090598 32855090599 32855090609 32855090615 32855090622 32855090628 32855090636 32855090637 32855090638 32855090640 32855090658 32855090659 32855090661 32855090715 32855090734 32855510763 32855510796 32855510797 32855510799 32855510800 3285

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Distribution

Distributed nationwide.

Key facts

Status

Terminated

Initiation date

2019-10-10

Report date

2019-11-13

Termination date

2020-05-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0302-2020