CLASS II Device recall · Reported 22 Feb 2017 · FDA Enforcement Report
LIMA Modular Revision Hip Stem recalled by Encore Medical
Encore Medical is recalling LIMA Modular Revision Hip Stem, distributed nationwide in the US. The recall was initiated on 10 Jan 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1191-2017
- FDA event ID
- 76209
- Recalling firm
- Encore Medical, Austin, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jan 2017
- FDA classified
- 10 Feb 2017
- Reported
- 22 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Hidden Drug Ingredients
- Device type
- Hip & Knee Implants
Timeline
| 10 Jan 2017 | Recall initiated by company | |
| 10 Feb 2017 | Classified by FDA | +31 days |
| 22 Feb 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
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Product as listed by the FDA
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.
Where it was distributed
US Nationwide - US Nationwide in the states of MS, OH, RI, NY, OK, TX, CA, HI
Nationwide CaliforniaHawaiiMississippiNew YorkOhioOklahomaRhode IslandTexas
Questions about this recall
Is LIMA Modular Revision Hip Stem recalled?
Yes. Encore Medical recalled LIMA Modular Revision Hip Stem on 10 Jan 2017. The recall is Class II and its status is Terminated. Recall number Z-1191-2017.
Why was it recalled?
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.
Which lots are affected?
1005528A, 1006882A, 1107305A, 1101798A, 1100565A, 1005531A, 1211716A, 1007408A, 1004038B, 1005533D, 1106805A, 1203471A, 1005533C, 1100565A, 1101795A, 1007079A, 1005532A, 1100560A
Where was it sold?
US Nationwide - US Nationwide in the states of MS, OH, RI, NY, OK, TX, CA, HI
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Encore Medical
All 99| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Empowr 3d Knee Ins, Ve recalled by Encore Medical | Encore Medical | Packaging Defects | 14 states |
| Device | CLASS II | Empowr 3d Knee Ins, Ve recalled by Encore Medical | Encore Medical | Packaging Defects | 14 states |
| Device | CLASS II | Empowr 3d Knee Ins, Ve recalled by Encore Medical | Encore Medical | Labeling Errors | Nationwide |
| Device | CLASS II | Reverse Shoulder Prosthesis recalled by Encore Medical | Encore Medical | Labeling Errors | Nationwide |
| Device | CLASS II | Reverse Shoulder Prosthesis recalled by Encore Medical | Encore Medical | Labeling Errors | Nationwide |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |