LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage:… — Class II medical device recall Z-1191-2017
Terminated recall by Encore Medical, Lp, reported 2017-02-22, distributed nationwide. Lima Proximal Bodies were inadvertently re-sterilized. The safety screw which affixes the distal and proximal
| Recall number | Z-1191-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, Lp, Austin, TX, United States |
| Recall initiated | 2017-01-10 |
| Classified | 2017-02-10 |
| Reported by FDA | 2017-02-22 |
| Terminated | 2017-03-31 |
| Distributed | Nationwide (US) |
| Quantity | 13 devices |
| Reason classes | unapproved product |
Product
LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The Modular Revision Femoral hip stem is made up of a modular stem coupled with a proper neck by means of a Morse taper stabilized during the implantation phase by a safety screw. This system is particularly indicated for revision surgery on both uncemented and cemented femoral implants, when there is significant bone loss and an abnormal meta-epiphyseal anatomy of the femur.
Reason for recall
Lima Proximal Bodies were inadvertently re-sterilized. The safety screw which affixes the distal and proximal bodies of the stem includes a thread-locking plug made from UHMWPE, which is not approved for repeated gamma sterilization.
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-1191-2017. 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.