FDA Medical Device Recalls (openFDA)
Medacta Usa Inc: Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surgery.
- Recall number
- Z-0196-2019
- Recalling firm
- Medacta Usa Inc
- Product
- Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surgery.
- Status
- Terminated
- Initiated
- 2017-11-15
- Posted
- not on file
- Terminated
- 2019-03-29
- Reason
- Complaint monitoring noted a trend of packaging being breached for the MiniMAX Stem.
- Root cause
- Package design/selection
- Action
- The firm initiated the recall by telephone to its distributors. The firm requested return of all recalled units.
- Quantity
- 837 units
- Distribution
- NC, ID, Belgium, Switzerland, Spain, Germany, Australia, France, Italy
- Lot, serial or model codes
- a) REF 01.13.100L, GTIN 07630030803130 b) REF 01.13.101L, GTIN 07630030803154 c) REF 01.13.102L, GTIN 07630030803178 d) REF 01.13.103L, GTIN 07630030803192 e) REF 01.13.104L, GTIN 07630030803215 f) REF 01.13.105L, GTIN 07630030803239 g) REF 01.13.106L, GTIN 07630030803253 h) REF 01.13.107L, GTIN 07630030803277 I) REF 01.13.108L, GTIN 07630030803291 j) REF 01.13.100R, GTIN 07630030803147 k) REF 01.13.101R, GTIN 07630030803161 l) REF 01.13.102R, GTIN 07630030803185 m) REF 01.13.103R, GTIN 07630030803208 n) REF 01.13.104R, GTIN 07630030803222 o) REF 01.13.105R, GTIN 07630030803246 p) REF 01.13.106R, GTIN 07630030803260 q) REF 01.13.107R, GTIN 07630030803284 r) REF 01.13.108R, GTIN 07630030803307 Lots produced with the old version of the packaging, including lot numbers less than 169041.
- 510(k) numbers
- ["K170845"]
- PMA numbers
- not on file
- Product code
- LZO
- Firm FEI
- 3006639916
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28